Negative Pressure Therapy System

ABSTRACT

Negative pressure therapy systems are provided for increasing urine production, the negative pressure therapy system including: (a) a pump assembly, the pump assembly including: (i) a pump configured to provide negative pressure to a kidney, and (ii) a controller configured to regulate the negative pressure provided by the pump within a pressure range that facilitates increased urine production from the kidney.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/036,971, filed Jul. 17, 2018, which is a continuation of U.S.application Ser. No. 15/214,955, filed Jul. 20, 2016, now issued as U.S.Pat. No. 10,307,564, which claims the benefit of U.S. ProvisionalApplication No. 62/194,585, filed Jul. 20, 2015, U.S. ProvisionalApplication No. 62/260,966 filed Nov. 30, 2015, U.S. ProvisionalApplication No. 62/278,721, filed Jan. 14, 2016, and U.S. ProvisionalApplication No. 62/300,025 filed Feb. 25, 2016, each of which isincorporated herein by reference in its entirety.

BACKGROUND Technical Field

The present disclosure relates to methods and devices for treatingimpaired renal function across a variety of disease states and, inparticular, to catheter devices, assemblies, and methods for collectionof urine and/or inducement of negative pressure in the ureters and/orkidneys.

Background

The renal or urinary system includes a pair of kidneys, each kidneybeing connected by a ureter to the bladder, and a urethra for drainingurine produced by the kidneys from the bladder. The kidneys performseveral vital functions for the human body including, for example,filtering the blood to eliminate waste in the form of urine. The kidneysalso regulate electrolytes (e.g., sodium, potassium and calcium) andmetabolites, blood volume, blood pressure, blood pH, fluid volume,production of red blood cells, and bone metabolism. Adequateunderstanding of the anatomy and physiology of the kidneys is useful forunderstanding the impact that altered hemodynamics other fluid overloadconditions have on their function.

In normal anatomy, the two kidneys are located retroperitoneally in theabdominal cavity. The kidneys are bean-shaped encapsulated organs. Urineis formed by nephrons, the functional unit of the kidney, and then flowsthrough a system of converging tubules called collecting ducts. Thecollecting ducts join together to form minor calyces, then majorcalyces, which ultimately join near the concave portion of the kidney(renal pelvis). A major function of the renal pelvis is to direct urineflow to the ureter. Urine flows from the renal pelvis into the ureter, atube-like structure that carries the urine from the kidneys into thebladder. The outer layer of the kidney is called the cortex, and is arigid fibrous encapsulation. The interior of the kidney is called themedulla. The medulla structures are arranged in pyramids.

Each kidney is made up of approximately one million nephrons. Eachnephron includes the glomerulus, Bowman's capsule, and tubules. Thetubules include the proximal convoluted tubule, the loop of Henle, thedistal convoluted tubule, and the collecting duct. The nephronscontained in the cortex layer of the kidney are distinct from theanatomy of those contained in the medulla. The principal difference isthe length of the loop of Henle. Medullary nephrons contain a longerloop of Henle, which, under normal circumstances, allows greaterregulation of water and sodium reabsorption than in the cortex nephrons.

The glomerulus is the beginning of the nephron, and is responsible forthe initial filtration of blood. Afferent arterioles pass blood into theglomerular capillaries, where hydrostatic pressure pushes water andsolutes into Bowman's capsule. Net filtration pressure is expressed asthe hydrostatic pressure in the afferent arteriole minus the hydrostaticpressure in Bowman's space minus the osmotic pressure in the efferentarteriole.

Net Filtration Pressure=Hydrostatic Pressure (AfferentArteriole)−Hydrostatic Pressure (Bowman's Space)−Osmotic Pressure(Efferent Arteriole)  (Equation 1)

The magnitude of this net filtration pressure defined by Equation 1determines how much ultra-filtrate is formed in Bowman's space anddelivered to the tubules. The remaining blood exits the glomerulus viathe efferent arteriole. Normal glomerular filtration, or delivery ofultra-filtrate into the tubules, is about 90 ml/min/1.73 m².

The glomerulus has a three-layer filtration structure, which includesthe vascular endothelium, a glomerular basement membrane, and podocytes.Normally, large proteins such as albumin and red blood cells, are notfiltered into Bowman's space. However, elevated glomerular pressures andmesangial expansion create surface area changes on the basement membraneand larger fenestrations between the podocytes allowing larger proteinsto pass into Bowman's space.

Ultra-filtrate collected in Bowman's space is delivered first to theproximal convoluted tubule. Re-absorption and secretion of water andsolutes in the tubules is performed by a mix of active transportchannels and passive pressure gradients. The proximal convoluted tubulesnormally reabsorb a majority of the sodium chloride and water, andnearly all glucose and amino acids that were filtered by the glomerulus.The loop of Henle has two components that are designed to concentratewastes in the urine. The descending limb is highly water permeable andreabsorbs most of the remaining water. The ascending limb reabsorbs 25%of the remaining sodium chloride, creating a concentrated urine, forexample, in terms of urea and creatinine. The distal convoluted tubulenormally reabsorbs a small proportion of sodium chloride, and theosmotic gradient creates conditions for the water to follow.

Under normal conditions, there is a net filtration of approximately 14mmHg. The impact of venous congestion can be a significant decrease innet filtration, down to approximately 4 mmHg. See Jessup M., Thecardiorenal syndrome: Do we need a change of strategy or a change oftactics?, JACC 53(7):597-600, 2009 (hereinafter “Jessup”). The secondfiltration stage occurs at the proximal tubules. Most of the secretionand absorption from urine occurs in tubules in the medullary nephrons.Active transport of sodium from the tubule into the interstitial spaceinitiates this process. However, the hydrostatic forces dominate the netexchange of solutes and water. Under normal circumstances, it isbelieved that 75% of the sodium is reabsorbed back into lymphatic orvenous circulation. However, because the kidney is encapsulated, it issensitive to changes in hydrostatic pressures from both venous andlymphatic congestion. During venous congestion the retention of sodiumand water can exceed 85%, further perpetuating the renal congestion. SeeVerbrugge et al., The kidney in congestive heart failure: Arenatriuresis, sodium, and diruetucs really the good, the bad and theugly? European Journal of Heart Failure 2014:16, 133-42 (hereinafter“Verbrugge”).

Venous congestion can lead to a prerenal form of acute kidney injury(AKI). Prerenal AKI is due to a loss of perfusion (or loss of bloodflow) through the kidney. Many clinicians focus on the lack of flow intothe kidney due to shock. However, there is also evidence that a lack ofblood flow out of the organ due to venous congestion can be a clinicallyimportant sustaining injury. See Damman K, Importance of venouscongestion for worsening renal function in advanced decompensated heartfailure, JACC 17:589-96, 2009 (hereinafter “Damman”).

Prerenal AKI occurs across a wide variety of diagnoses requiringcritical care admissions. The most prominent admissions are for sepsisand Acute Decompensated Heart Failure (ADHF). Additional admissionsinclude cardiovascular surgery, general surgery, cirrhosis, trauma,burns, and pancreatitis. While there is wide clinical variability in thepresentation of these disease states, a common denominator is anelevated central venous pressure. In the case of ADHF, the elevatedcentral venous pressure caused by heart failure leads to pulmonaryedema, and, subsequently, dyspnea in turn precipitating the admission.In the case of sepsis, the elevated central venous pressure is largely aresult of aggressive fluid resuscitation. Whether the primary insult waslow perfusion due to hypovolemia or sodium and fluid retention, thesustaining injury is the venous congestion resulting in inadequateperfusion.

Hypertension is another widely recognized state that createsperturbations within the active and passive transport systems of thekidney(s). Hypertension directly impacts afferent arteriole pressure andresults in a proportional increase in net filtration pressure within theglomerulus. The increased filtration fraction also elevates theperitubular capillary pressure, which stimulates sodium and waterre-absorption. See Verbrugge.

Because the kidney is an encapsulated organ, it is sensitive to pressurechanges in the medullary pyramids. The elevated renal venous pressurecreates congestion that leads to a rise in the interstitial pressures.The elevated interstitial pressures exert forces upon both theglomerulus and tubules. See Verburgge. In the glomerulus, the elevatedinterstitial pressures directly oppose filtration. The increasedpressures increase the interstitial fluid, thereby increasing thehydrostatic pressures in the interstitial fluid and peritubularcapillaries in the medulla of the kidney. In both instances, hypoxia canensue leading to cellular injury and further loss of perfusion. The netresult is a further exacerbation of the sodium and water re-absorptioncreating a negative feedback. See Verbrugge, 133-42. Fluid overload,particularly in the abdominal cavity is associated with many diseasesand conditions, including elevated intra-abdominal pressure, abdominalcompartment syndrome, and acute renal failure. Fluid overload can beaddressed through renal replacement therapy. See Peters, C. D., Shortand Long-Term Effects of the Angiotensin II Receptor BlockerIrbesartanon Intradialytic Central Hemodynamics: A RandomizedDouble-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIRStudy), PLoS ONE (2015) 10(6): e0126882.doi:10.1371/journal.pone.0126882 (hereinafter “Peters”). However, such aclinical strategy provides no improvement in renal function for patientswith the cardiorenal syndrome. See Bart B, Ultrafiltration indecompensated heart failure with cardiorenal syndrome, NEJM 2012;367:2296-2304 (hereinafter “Bart”).

In view of such problematic effects of fluid retention, devices andmethods for improving removal of urine from the urinary tract and,specifically for increasing quantity and quality of urine output fromthe kidneys, are needed.

SUMMARY

In some examples, ureteral catheters are provided comprising: a drainagelumen comprising a proximal portion configured to be positioned in atleast a portion of a patient's urethra and a distal portion configuredto be positioned in a patient's ureter and/or kidney, the distal portioncomprising a coiled retention portion, wherein the retention portioncomprises at least a first coil having a first diameter and a secondcoil having a second diameter, the first diameter being less than thesecond diameter.

In some examples, a urine collection assembly is provided comprising: atleast one ureteral catheter comprising: a drainage lumen comprising aproximal portion configured to be positioned in at least a portion of apatient's urethra and a distal portion configured to be positioned in apatient's ureter and/or kidney, the distal portion comprising a coiledretention portion, wherein the retention portion comprises at least afirst coil having a first diameter and a second coil having a seconddiameter, the first diameter being less than the second diameter; and abladder catheter for deployment within the patient's bladder, thebladder catheter comprising: a drainage lumen portion defining adrainage lumen and comprising a proximal end, a distal end configured tobe positioned in the patient's bladder, and a sidewall extendingtherebetween; and a deployable anchor portion comprising a sealconfigured to contact a proximal portion of the bladder wall toessentially or fully seal the urethral opening of the bladder, whereinthe drainage lumen portion or the anchor portion comprises at least onedrainage port for permitting fluid flow into the drainage lumen.

In some examples, a ureteral catheter is provided comprising: a drainagelumen portion comprising a proximal end, a distal end configured to bepositioned in a patient's ureter and/or kidney, and a sidewall extendingtherebetween; and a retention portion extending radially outwardly froma portion of the distal end of the drainage lumen portion, the retentionportion comprising a proximal end having a first diameter, a distal endhaving a second diameter, and a wall and/or surface extendingtherebetween, the retention portion being configured to be extended intoa deployed position in which the second diameter is greater than thefirst diameter.

In some examples, a urine collection assembly is provided comprising: atleast one ureteral catheter comprising: a drainage lumen portioncomprising a proximal end, a distal end configured to be positioned in apatient's ureter and/or kidney, and a sidewall extending therebetween;and a retention portion extending radially outwardly from a portion ofthe distal end of the drainage lumen portion, the retention portioncomprising a proximal end having a first diameter, a distal end having asecond diameter, and a wall and/or surface extending therebetween, theretention portion being configured to be extended into a deployedposition in which the second diameter is greater than the firstdiameter; and a bladder catheter for deployment within the patient'sbladder, the bladder catheter comprising: a drainage lumen portiondefining a drainage lumen and comprising a proximal end, a distal endconfigured to be positioned in the patient's bladder, and a sidewallextending therebetween; and a deployable anchor portion comprising aseal configured to contact a proximal portion of the bladder wall toseal the urethral opening of the bladder, wherein the drainage lumenportion or the anchor portion comprises at least one drainage port forpermitting fluid flow into the drainage lumen.

In some examples, a ureteral catheter is provided comprising: a drainagelumen portion comprising a proximal end, a distal end configured to bepositioned in a patient's ureter and/or kidney, and a sidewall extendingtherebetween, the drainage lumen portion defining a drainage lumen; anda retention portion which, in a deployed position, extends radiallyoutwardly from a portion of the distal end of the drainage lumenportion, the retention portion comprising a plurality of tubes extendingbetween a proximal end of the retention portion and a distal end of theretention portion, wherein each tube defines a lumen in fluidcommunication with the drainage lumen defined by the drainage lumenportion and wherein each tube comprises a plurality of drainage portsfor allowing fluid to enter the lumen.

In some examples, a urine collection assembly is provided comprising: atleast one ureteral catheter comprising: a drainage lumen portioncomprising a proximal end, a distal end configured to be positioned in apatient's ureter and/or kidney, and a sidewall extending therebetween,the drainage lumen portion defining a drainage lumen; and a retentionportion which, in a deployed position, extends radially outward from aportion of the distal end of the drainage lumen portion, the retentionportion comprising a plurality of tubes extending between a proximal endof the retention portion and a distal end of the retention portion,wherein each tube defines a lumen in fluid communication with thedrainage lumen defined by the drainage lumen portion and wherein eachtube comprises a plurality of drainage ports for allowing fluid to enterthe lumen; and a bladder catheter for deployment within the patient'sbladder, the bladder catheter comprising: a drainage lumen portiondefining a drainage lumen and comprising a proximal end, a distal endconfigured to be positioned in the patient's bladder, and a sidewallextending therebetween; and a deployable anchor portion comprising aseal configured to contact a proximal portion of the bladder wall toseal the urethral opening of the bladder, wherein the drainage lumenportion or the anchor portion comprises at least one drainage port forpermitting fluid flow into the drainage lumen.

In some examples, a connector is provided for connecting ureteralcatheters configured to be positioned at a patient's ureter and/orkidney to a vacuum source for inducing negative pressure in the ureterand/or kidney and for connecting a bladder catheter to a fluidcollection container for fluid collection of urine from the bladder bygravity drainage, the connector comprising: a connector body; first andsecond ureteral catheter inflow ports extending from the connector body,the inflow ports each being configured to be connected to a ureteralcatheter positioned in a patient's ureter and/or kidney; a ureteralcatheter outflow port in fluid communication with each inflow port andbeing configured to be connected to a pump for inducing negativepressure in the respective ureteral catheters; a gravity drainage inflowport configured to be connected to a bladder catheter; and a gravitydrainage outflow port in fluid communication with the bladder catheterinflow port and being configured to be connected to a fluid collectioncontainer.

In some examples, a urine collection assembly is provided comprising: afirst ureteral catheter configured to be positioned in a patient'sureter and/or kidney and a second ureteral catheter configured to bepositioned in the patient's other ureter and/or kidney, the ureteralcatheters each comprising: a drainage lumen portion defining a drainagelumen and comprising a proximal end, a distal end configured to bepositioned in a patient's ureter and/or kidney, and a sidewall extendingtherebetween; and a retention portion extending radially outward from aportion of the distal end of the drainage lumen portion, and beingconfigured to be extended into a deployed position in which a diameterof the retention portion is greater than a diameter of the drainagelumen portion, wherein at least one of the drainage lumen portion or theretention portion comprises at least one drainage port to permit fluidflow into the drainage lumen; and a bladder catheter for deploymentwithin the patient's bladder, the bladder catheter comprising: adrainage lumen portion defining a drainage lumen and comprising aproximal end, a distal end configured to be positioned in the patient'sbladder, and a sidewall extending therebetween; and a deployable anchorportion comprising a seal configured to contact a proximal portion ofthe bladder wall to seal the urethral opening, wherein at least one ofthe drainage lumen portion or the anchor portion comprises at least onedrainage port for permitting fluid flow into the drainage lumen.

In some examples, a bladder catheter is provided for deployment withinthe patient's bladder for collecting excess urine not collected bydeployed ureteral catheters positioned in the patient's ureter and/orkidney, the bladder catheter comprising: a drainage lumen portiondefining a drainage lumen and comprising a proximal end portion, adistal end portion configured to be positioned in the patient's bladder,and a sidewall extending therebetween; and a deployable anchor portionconfigured to contact a proximal portion of the bladder wall to seal theurethral opening, wherein at least one of the drainage lumen portion orthe anchor portion comprises at least one drainage port for permittingfluid flow into the drainage lumen for expelling urine from the bladder.

In some examples, a system is provided for inducing negative pressure ina portion of a urinary tract of a patient, the system comprising: aureteral catheter comprising: a drainage lumen portion comprising aproximal end, a distal end configured to be positioned in a patient'sureter and/or kidney, and a sidewall extending therebetween; and aretention portion extending radially outward from a portion of thedistal end of the drainage lumen portion, and being configured to beextended into a deployed position in which a diameter of the retentionportion is greater than a diameter of the drainage lumen portion,wherein at least one of the drainage lumen portion or the retentionportion comprises at least one drainage port to permit fluid flow intothe drainage lumen; and a pump in fluid communication with a drainagelumen defined by the drainage lumen portion of the ureteral catheter,the pump being configured for inducing a negative pressure in a portionof the urinary tract of the patient to draw fluid through the drainagelumen of the ureteral catheter.

Methods of using the above catheters and assemblies also are provided.

In some examples, a method is provided for extracting urine from aureter and/or kidney of a patient for effecting interstitial pressure inthe kidney, the method comprising: positioning a distal end of acatheter at a fluid collection position within a patient's ureter and/orkidney, the catheter comprising a tube defining a drainage lumen andcomprising a helical retention portion and a plurality of drainageports; inducing a negative pressure within a drainage lumen of thecatheter; and extracting urine by drawing urine through the drainageports into the drainage lumen, thereby altering interstitial pressurewithin the patient's kidney.

In some examples, a method is provided for inhibiting kidney damage byapplication of negative pressure to decrease interstitial pressurewithin tubules of the medullar region to facilitate urine output and toprevent venous congestion-induced nephron hypoxia in the medulla of thekidney, the method comprising: deploying a ureteral catheter in theureter and/or kidney of a patient such that flow of urine from theureter and/or kidney is not prevented by occlusion of the ureter and/orkidney by the deployed catheter; and applying negative pressure to theureter and/or kidney through the catheter for a predetermined period oftime to facilitate urine output from the kidney.

In some examples, a method is provided for treatment of acute kidneyinjury due to venous congestion, the method comprising: deploying aureteral catheter at a fluid collection position in the ureter and/orkidney of a patient such that the ureter and/or kidney is not occludedby the deployed catheter; and applying negative pressure to the ureterand/or kidney through the catheter for a predetermined period of time,thereby reducing venous congestion in the kidney to treat acute kidneyinjury.

In some examples, a method is provided for treatment of New York HeartAssociation (NYHA) Class III and/or Class IV heart failure throughreduction of venous congestion in the kidney(s), the method comprising:deploying a ureteral catheter in the ureter and/or kidney of a patientsuch that flow of urine from the ureter and/or kidney is not preventedby occlusion of the ureter and/or kidney; and applying negative pressureto the ureter and/or kidney through the catheter for a predeterminedperiod of time to treat volume overload in NYHA Class III and/or ClassIV heart failure.

In some examples, a method is provided for treatment of Stage 4 and/orStage 5 chronic kidney disease through reduction of venous congestion inthe kidney(s), the method comprising: deploying a ureteral catheter inthe ureter and/or kidney of a patient such that flow of urine from theureter and/or kidney is not prevented by occlusion of the ureter and/orkidney; and applying negative pressure to the ureter and/or kidneythrough the catheter for a predetermined period of time to treat Stage 4and/or Stage 5 chronic kidney disease.

Non-limiting examples, aspects or embodiments of the present inventionwill now be described in the following numbered clauses:

Clause 1: A ureteral catheter comprising: a drainage lumen comprising aproximal portion configured to be positioned in at least a portion of apatient's urethra and a distal portion configured to be positioned in apatient's ureter and/or kidney, the distal portion comprising a coiledretention portion, wherein the retention portion comprises at least afirst coil having a first diameter and a second coil having a seconddiameter, the first diameter being less than the second diameter.

Clause 2: The ureteral catheter of clause 1, wherein the first coil isproximal to the second coil.

Clause 3: The ureteral catheter of any of clause 1 or clause 2, wherein,prior to insertion into a patient's urinary tract, a portion of thedrainage lumen that is proximal to the retention portion defines astraight or curvilinear central axis, and wherein the first coil and thesecond coil of the retention portion extend about an axis that is atleast partially coextensive with the straight or curvilinear centralaxis of the portion of the drainage lumen.

Clause 4: The ureteral catheter of clause 1 or clause 2, wherein, priorto insertion to the patient's urinary tract, a portion of the drainagelumen that is proximal to the retention portion defines a straight orcurvilinear central axis, and wherein the first coil and the second coilof the retention portion extend about an axis that is essentiallycoextensive with the straight or curvilinear central axis of the portionof the drainage lumen.

Clause 5: The ureteral catheter of clause 3 or clause 4, wherein theaxis of the retention portion is curved relative to the central axis ofthe drainage lumen.

Clause 6: The ureteral catheter of any of clauses 1 to 5, wherein aportion of the drainage lumen that is proximal to the retention portiondefines a straight or curvilinear central axis, and wherein the firstcoil and the second coil of the retention portion extend about an axisof the retention portion, the axis of the retention portion beingpositioned at an angle from the central axis ranging from about 15degrees to about 75 degrees.

Clause 7: The ureteral catheter of any of clauses 1 to 6, wherein thecatheter is transitionable between a contracted configuration forinsertion into the patient's ureter and a deployed configuration fordeployment within the ureter.

Clause 8: The ureteral catheter of any of clauses 1 to 7, wherein theretention portion further comprises a third coil, the third coil havinga diameter greater than or equal to either the first diameter or thesecond diameter.

Clause 9: The ureteral catheter of any of clauses 1 to 8, wherein theretention portion comprises a tube comprising perforations forpermitting fluid to be received within the lumen of the tube.

Clause 10: The ureteral catheter of clause 9, wherein, in the retentionportion, the tube comprises a radially inwardly facing side and aradially outwardly facing side, and wherein a total surface area forperforations on the radially inwardly facing side is greater than atotal surface area of perforations on the radially outwardly facingside.

Clause 11: The ureteral catheter of clause 9, wherein, in the retentionportion, the tube comprises a radially inwardly facing side and aradially outwardly facing side, and wherein the perforations aredisposed on the radially inwardly facing side, and wherein the radiallyoutwardly facing side of the tube is essentially free of perforations.

Clause 12: The ureteral catheter of clause 11, wherein the radiallyoutwardly facing side of the tube is free of perforations.

Clause 13: The ureteral catheter of any of clauses 1 to 12, wherein thetube is formed, at least in part, from one or more of copper, silver,gold, nickel-titanium alloy, stainless steel, titanium, polyurethane,polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone.

Clause 14: A urine collection assembly comprising: at least one ureteralcatheter comprising: a drainage lumen comprising a proximal portionconfigured to be positioned in at least a portion of a patient's urethraand a distal portion configured to be positioned in a patient's ureterand/or kidney, the distal portion comprising a coiled retention portion,wherein the retention portion comprises at least a first coil having afirst diameter and a second coil having a second diameter, the firstdiameter being less than the second diameter; and a bladder catheter fordeployment within the patient's bladder, the bladder cathetercomprising: a drainage lumen portion defining a drainage lumen andcomprising a proximal end, a distal end configured to be positioned inthe patient's bladder, and a sidewall extending therebetween; and adeployable anchor portion comprising a seal configured to contact aproximal portion of the bladder wall to essentially or fully seal theurethral opening of the bladder, wherein the drainage lumen portion orthe anchor portion comprises at least one drainage port for permittingfluid flow into the drainage lumen.

Clause 15: The assembly of clause 14, wherein the drainage lumen portionof the at least one ureteral catheter is removably received through thedrainage port of the bladder catheter, such that the proximal end of theat least one ureteral catheter is disposed within the drainage lumen ofthe bladder catheter.

Clause 16: The assembly of any of clauses 14 or 15, wherein thedeployable anchor portion of the bladder catheter comprises aninflatable element or balloon in fluid communication with an inflationlumen defined by the drainage lumen portion of the bladder catheter.

Clause 17: The assembly of any of clauses 14 to 16, wherein the at leastone drainage port is disposed on a sidewall of the bladder catheter at aposition proximal to the deployable anchor portion.

Clause 18: The assembly of any of clauses 14 to 17, wherein thedeployable anchor portion comprises an expandable cage comprising aplurality of flexible members extending radially and longitudinally fromthe drainage lumen portion of the bladder catheter.

Clause 19: The assembly of any of clauses 14 to 18, wherein thedeployable anchor portion comprises a plurality of longitudinallyextending members that, in a deployed position, extend radially andlongitudinally outwardly from a portion of the distal end of the bladdercatheter, thereby forming a cage.

Clause 20: The assembly of clause 18, wherein the deployable anchorfurther comprises a flexible cover extending about an upper portion ofthe cage.

Clause 21: The assembly of clause 20, wherein the cover extends over atleast about the upper half, or at about least the upper ⅔, of the cage.

Clause 22: The assembly of any of clauses 14 to 21, wherein the drainagelumen of the at least one ureteral catheter is separate from thedrainage lumen of the bladder along an entire length of the catheters.

Clause 23: A ureteral catheter comprising: a drainage lumen portioncomprising a proximal end, a distal end configured to be positioned in apatient's ureter and/or kidney, and a sidewall extending therebetween;and a retention portion extending radially outwardly from a portion ofthe distal end of the drainage lumen portion, the retention portioncomprising a proximal end having a first diameter, a distal end having asecond diameter, and a wall and/or surface extending therebetween, theretention portion being configured to be extended into a deployedposition in which the second diameter is greater than the firstdiameter.

Clause 24: The ureteral catheter of clause 23, wherein the retentionportion comprises an expandable element or balloon in fluidcommunication with an inflation lumen extending along the drainage lumenportion.

Clause 25: The ureteral catheter of clause 23 or clause 24, wherein theretention portion comprises a coiled tube extending from the distal endof the drainage lumen portion, the tube defining a lumen in fluidcommunication with the drainage lumen defined by the drainage lumenportion.

Clause 26: The ureteral catheter of any of clauses 23 to 25, wherein thecoiled tube comprises perforations extending through a sidewall of thetube for permitting fluid to be received within the lumen.

Clause 27: The ureteral catheter of clause 26, wherein the perforationsare disposed on a radially inwardly facing portion of the tube, andwherein an opposing radially outwardly facing portion of the tube isessentially free of perforations.

Clause 28: The ureteral catheter of clause 27, wherein the opposingradially outwardly facing portion of the tube is free of perforations.

Clause 29: The ureteral catheter of any of clauses 23 to 28, wherein thedrainage lumen portion and the retention portion are formed, at least inpart, from one or more of copper, silver, gold, nickel-titanium alloy,stainless steel, titanium, polyurethane, polyvinyl chloride,polytetrafluoroethylene (PTFE), latex, and silicone.

Clause 30: The ureteral catheter of clause 23, wherein the retentionportion comprises a wedge or funnel-shaped extension formed from acompressible and/or porous material.

Clause 31: The ureteral catheter of any of clauses 23 to 30, wherein theretention portion is integrally formed with the drainage lumen portion.

Clause 32: The ureteral catheter of any of clauses 23 to 31, wherein theretention portion further comprises a tapered inner surface configuredto direct fluid towards the drainage lumen defined by the drainage lumenportion.

Clause 33: The ureteral catheter of any of clauses 23 to 32, wherein thedrainage lumen of the catheter is configured to be pressurized to anegative pressure for fluid collection from the ureter and/or kidney.

Clause 34: A urine collection assembly comprising: at least one ureteralcatheter comprising: a drainage lumen portion comprising a proximal end,a distal end configured to be positioned in a patient's ureter and/orkidney, and a sidewall extending therebetween; and a retention portionextending radially outwardly from a portion of the distal end of thedrainage lumen portion, the retention portion comprising a proximal endhaving a first diameter, a distal end having a second diameter, and awall and/or surface extending therebetween, the retention portion beingconfigured to be extended into a deployed position in which the seconddiameter is greater than the first diameter; and a bladder catheter fordeployment within the patient's bladder, the bladder cathetercomprising: a drainage lumen portion defining a drainage lumen andcomprising a proximal end, a distal end configured to be positioned inthe patient's bladder, and a sidewall extending therebetween; and adeployable anchor portion comprising a seal configured to contact aproximal portion of the bladder wall to seal the urethral opening of thebladder, wherein the drainage lumen portion or the anchor portioncomprises at least one drainage port for permitting fluid flow into thedrainage lumen.

Clause 35: The assembly of clause 34, wherein the drainage lumen portionof the at least one ureteral catheter is removably received through thedrainage port of the bladder catheter, such that the proximal end of theat least one ureteral catheter is disposed within the drainage lumen ofthe bladder catheter.

Clause 36: The assembly of clause 34 or clause 35, wherein thedeployable anchor portion of the bladder catheter comprises aninflatable element or balloon in fluid communication with an inflationlumen defined by the drainage lumen portion of the bladder catheter.

Clause 37: The assembly of any of clauses 34 to 36, wherein the at leastone drainage port is disposed on a sidewall of the bladder catheter at aposition proximal to the deployable anchor portion.

Clause 38: The assembly of clause 34, wherein the deployable anchorportion comprises an expandable cage comprising a plurality of flexiblemembers extending radially and longitudinally from the drainage lumenportion of the bladder catheter.

Clause 39: The assembly of clause 34, wherein the deployable anchorportion comprises a plurality of longitudinally extending members that,in a deployed position, extend radially and longitudinally outward froma portion of the distal end of the bladder catheter, thereby forming acage.

Clause 40: The assembly of clause 38 or clause 39, wherein thedeployable anchor further comprises a flexible cover extending about anupper portion of the cage.

Clause 41: The assembly of clause 40, wherein the cover extends over atleast about the upper half, or at least about the upper ⅔, of the cage.

Clause 42: A ureteral catheter comprising: a drainage lumen portioncomprising a proximal end, a distal end configured to be positioned in apatient's ureter and/or kidney, and a sidewall extending therebetween,the drainage lumen portion defining a drainage lumen; and a retentionportion which, in a deployed position, extends radially outwardly from aportion of the distal end of the drainage lumen portion, the retentionportion comprising a plurality of tubes extending between a proximal endof the retention portion and a distal end of the retention portion,wherein each tube defines a lumen in fluid communication with thedrainage lumen defined by the drainage lumen portion and wherein eachtube comprises a plurality of drainage ports for allowing fluid to enterthe lumen.

Clause 43: The ureteral catheter of clause 42, wherein each tubecomprises a radially inwardly facing side and a radially outwardlyfacing side, and wherein the drainage ports are disposed on the radiallyinwardly facing side of each tube.

Clause 44: The ureteral catheter of clause 43, wherein the radiallyoutwardly facing side of each tube is essentially free of drainageports.

Clause 45: The ureteral catheter of clause 43, wherein the radiallyoutwardly facing side of each tube is free of drainage ports.

Clause 46: The ureteral catheter of any of clauses 42 to 45, wherein theretention portion is transitionable from a contracted position, in whicheach of the plurality of tubes is substantially parallel to alongitudinal axis of the drainage lumen portion and the deployedposition in which portions of the tubes extend radially outwardly fromthe drainage lumen portion.

Clause 47: The ureteral catheter of any of clauses 42 to 46, wherein inthe deployed position the tubes define a spherical or ellipsoidalcavity, and wherein the drainage lumen portion extends at leastpartially into the cavity.

Clause 48: The ureteral catheter of any of clauses 42 to 47, wherein thedrainage lumen portion and the retention portion are formed, at least inpart, from one or more of copper, silver, gold, nickel-titanium alloy,stainless steel, titanium, polyurethane, polyvinyl chloride,polytetrafluoroethylene (PTFE), latex, and silicone.

Clause 49: The ureteral catheter of any of clauses 42 to 48, wherein theretention portion is integrally formed with the drainage lumen portion.

Clause 50: The ureteral catheter of any of clauses 42 to 49, wherein thedrainage lumen of the catheter is configured to be pressurized to anegative pressure for fluid collection from the ureter and/or kidney.

Clause 51: A urine collection assembly comprising: at least one ureteralcatheter comprising: a drainage lumen portion comprising a proximal end,a distal end configured to be positioned in a patient's ureter and/orkidney, and a sidewall extending therebetween, the drainage lumenportion defining a drainage lumen; and a retention portion which, in adeployed position, extends radially outward from a portion of the distalend of the drainage lumen portion, the retention portion comprising aplurality of tubes extending between a proximal end of the retentionportion and a distal end of the retention portion, wherein each tubedefines a lumen in fluid communication with the drainage lumen definedby the drainage lumen portion and wherein each tube comprises aplurality of drainage ports for allowing fluid to enter the lumen; and abladder catheter for deployment within the patient's bladder, thebladder catheter comprising: a drainage lumen portion defining adrainage lumen and comprising a proximal end, a distal end configured tobe positioned in the patient's bladder, and a sidewall extendingtherebetween; and a deployable anchor portion comprising a sealconfigured to contact a proximal portion of the bladder wall to seal theurethral opening of the bladder, wherein the drainage lumen portion orthe anchor portion comprises at least one drainage port for permittingfluid flow into the drainage lumen.

Clause 52: The assembly of clause 51, wherein the drainage lumen portionof the at least one ureteral catheter is removably received through thedrainage port of the bladder catheter, such that the proximal end of theat least one ureteral catheter is disposed within the drainage lumen ofthe bladder catheter.

Clause 53: The assembly of clause 51 or clause 52, wherein thedeployable anchor portion of the bladder catheter comprises aninflatable element or balloon in fluid communication with an inflationlumen defined by the drainage lumen portion of the bladder catheter.

Clause 54: The assembly of any of clauses 51 to 53, wherein the at leastone drainage port is disposed on a sidewall of the bladder catheter at aposition proximal to the deployable anchor portion.

Clause 55: The assembly of clause 51 or clause 52, wherein thedeployable anchor portion comprises an expandable cage comprising aplurality of flexible members extending radially and longitudinally fromthe drainage lumen portion of the bladder catheter.

Clause 56: The assembly of clause 51 or clause 52, wherein thedeployable anchor portion comprises a plurality of longitudinallyextending members that, in a deployed position, extend radially andlongitudinally outward from a portion of the distal end of the bladdercatheter, thereby forming a cage.

Clause 57: The assembly of clause 55 or clause 56, wherein thedeployable anchor further comprises a flexible cover extending about anupper portion of the cage.

Clause 58: The assembly of clause 57, wherein the cover extends over atleast about the upper half, or about the upper ⅔, of the cage.

Clause 59: A connector for connecting ureteral catheters configured tobe positioned at a patient's ureter and/or kidney to a vacuum source forinducing negative pressure in the ureter and/or kidney and forconnecting a bladder catheter to a fluid collection container for fluidcollection of urine from the bladder by gravity drainage, the connectorcomprising: a connector body; first and second ureteral catheter inflowports extending from the connector body, the inflow ports each beingconfigured to be connected to a ureteral catheter positioned in apatient's ureter and/or kidney; a ureteral catheter outflow port influid communication with each inflow port and being configured to beconnected to a pump for inducing negative pressure in the respectiveureteral catheters; a gravity drainage inflow port configured to beconnected to the bladder catheter; and a gravity drainage outflow portin fluid communication with the bladder catheter inflow port and beingconfigured to be connected to a fluid collection container.

Clause 60: The connector of clause 59, wherein the connector bodydefines a fluid conduit extending from the at least two ureteralcatheter inflow ports to the single ureteral catheter outflow port.

Clause 61: The connector of clause 59 or clause 60, wherein the inflowports are configured to removably receive ends of the respectivecatheters.

Clause 62: The connector of any of clauses 59 to 61, wherein the vacuumoutflow port and the gravity drainage outflow port are positioned forconnection to a single socket for establishing fluid connection with thepump and fluid connection container.

Clause 63: A urine collection assembly comprising: a first ureteralcatheter configured to be positioned in a patient's ureter and/or kidneyand a second ureteral catheter configured to be positioned in thepatient's other ureter and/or kidney, the ureteral catheters eachcomprising: a drainage lumen portion defining a drainage lumen andcomprising a proximal end, a distal end configured to be positioned in apatient's ureter and/or kidney, and a sidewall extending therebetween;and a retention portion extending radially outward from a portion of thedistal end of the drainage lumen portion, and being configured to beextended into a deployed position in which a diameter of the retentionportion is greater than a diameter of the drainage lumen portion,wherein at least one of the drainage lumen portion or the retentionportion comprises at least one drainage port to permit fluid flow intothe drainage lumen; and a bladder catheter for deployment within thepatient's bladder, the bladder catheter comprising: a drainage lumenportion defining a drainage lumen and comprising a proximal end, adistal end configured to be positioned in the patient's bladder, and asidewall extending therebetween; and a deployable anchor portioncomprising a seal configured to contact a proximal portion of thebladder wall to seal the urethral opening, wherein at least one of thedrainage lumen portion or the anchor portion comprises at least onedrainage port for permitting fluid flow into the drainage lumen.

Clause 64: The assembly of clause 63, further comprising a connector forconnecting proximal ends of the ureteral catheters to a vacuum sourceand for connecting the proximal end of the bladder catheter to a fluidcollection container for fluid collection by gravity drainage.

Clause 65: The assembly of clause 64, wherein the connector comprises:at least two ureteral catheter inflow ports for connection to therespective proximal ends of the first ureteral catheter and the secondureteral catheter; a ureteral catheter outflow port in fluidcommunication with each inflow port and being configured to be connectedto a pump for inducing negative pressure in the respective ureteralcatheters; a gravity drainage inflow port configured to be connected tothe proximal end of the bladder catheter; and an outflow port in fluidcommunication with the bladder catheter inflow port and being configuredto be connected to a fluid collection container.

Clause 66: The assembly of clause 65, wherein the connector furthercomprises conduit extending from the at least two ureteral catheterinflow ports to the single ureteral catheter outflow port.

Clause 67: The assembly of clause 65 or clause 66, wherein the proximalends of the respective catheters are removably connected to theirrespective inflow ports.

Clause 68: The assembly of any clauses 63 to 67, wherein the deployableanchor portion of the bladder catheter comprises an inflatable elementor balloon in fluid communication with an inflation lumen defined by thedrainage lumen portion of the bladder catheter.

Clause 69: The assembly of clause 63, wherein the deployable anchorportion comprises an expandable cage comprising a plurality of flexiblemembers extending radially and longitudinally from the drainage lumenportion of the bladder catheter and a cover enclosing at least a portionof the cage.

Clause 70: The assembly of clause 68 or clause 69, wherein thedeployable anchor further comprises a flexible cover extending about anupper portion of the cage.

Clause 71: The assembly of clause 70, wherein the cover extends over atleast about the upper half, or at least about the upper ⅔, of the cage.

Clause 72: A bladder catheter for deployment within the patient'sbladder for collecting excess urine not collected by deployed ureteralcatheters positioned in the patient's ureter and/or kidney, the bladdercatheter comprising: a drainage lumen portion defining a drainage lumenand comprising a proximal end portion, a distal end portion configuredto be positioned in the patient's bladder, and a sidewall extendingtherebetween; and a deployable anchor portion configured to contact aproximal portion of the bladder wall to seal the urethral opening,wherein at least one of the drainage lumen portion or the anchor portioncomprises at least one drainage port for permitting fluid flow into thedrainage lumen for expelling urine from the bladder.

Clause 73: The bladder catheter of clause 72, wherein the deployableanchor portion comprises an inflatable element or balloon in fluidcommunication with an inflation lumen defined by the drainage lumenportion of the bladder catheter.

Clause 74: The bladder catheter of clause 73, wherein the inflatableelement or balloon comprises an upper portion configured to bepositioned in the patient's bladder and a lower portion configured to bepositioned in the patient's urethra.

Clause 75: The bladder catheter of any of clauses 62 to 74, wherein theat least one drainage port is disposed on a sidewall of the bladdercatheter at a position proximal to the anchor portion.

Clause 76: The bladder catheter of clause 72, wherein the deployableanchor portion comprises an expandable cage comprising a plurality offlexible members extending radially and longitudinally from the drainagelumen portion of the bladder catheter and a cover enclosing at least aportion of the cage.

Clause 77: The bladder catheter of clause 76, wherein the deployableanchor portion further comprises a flexible cover extending about anupper portion of the cage.

Clause 78: The bladder catheter of clause 77, wherein the cover extendsover at least about the upper half, or at least about the upper ⅔, ofthe cage.

Clause 79: A system for inducing negative pressure in a portion of aurinary tract of a patient, the system comprising: a ureteral cathetercomprising: a drainage lumen portion comprising a proximal end, a distalend configured to be positioned in a patient's ureter and/or kidney, anda sidewall extending therebetween; and a retention portion extendingradially outward from a portion of the distal end of the drainage lumenportion, and being configured to be extended into a deployed position inwhich a diameter of the retention portion is greater than a diameter ofthe drainage lumen portion, wherein at least one of the drainage lumenportion or the retention portion comprises at least one drainage port topermit fluid flow into the drainage lumen; and a pump in fluidcommunication with a drainage lumen defined by the drainage lumenportion of the ureteral catheter, the pump being configured for inducinga negative pressure in a portion of the urinary tract of the patient todraw fluid through the drainage lumen of the ureteral catheter.

Clause 80: The system of clause 79, further comprising: a bladdercatheter for deployment within the patient's bladder, the bladdercatheter comprising: a drainage lumen portion defining a drainage lumenand comprising a proximal end, a distal end configured to be positionedin the patient's bladder, and a sidewall extending therebetween; and adeployable anchor portion comprising a seal configured to contact aproximal portion of the bladder wall to seal the urethral opening,wherein at least one of the drainage lumen portion or the anchor portioncomprises at least one drainage port for permitting fluid flow into thedrainage lumen for expelling urine from the bladder.

Clause 81: The system of clause 80, further comprising an external fluidcollection container in fluid communication with the drainage lumen ofthe bladder catheter for gravity drainage of fluid through the bladdercatheter.

Clause 82: The system of any of clauses 79 to 81, further comprising oneor more sensors in fluid communication with the drainage lumen, the oneor more sensors being configured to determine information comprising atleast one of capacitance, analyte concentration, and temperature ofurine within the respective drainage lumen; and a processor comprisingcomputer readable memory including programming instructions that, whenexecuted, cause the processor to: receive the information from the oneor more sensors and adjust an operating parameter of the pump based, atleast in part, on the information received from the one or more sensorsto increase or decrease vacuum pressure in the drainage lumen of the atleast one ureteral catheter to adjust flow of urine through the drainagelumen.

Clause 83: The system of clause 82, further comprising a datatransmitter in communication with the processor, the data transmitterbeing configured to provide the information from the one or more sensorsto an external source.

Clause 84: The system of any of clauses 80 to 83, wherein the pumpprovides a sensitivity of 10 mmHg or less.

Clause 85: The system of any of clauses 80 to 84, wherein the pump iscapable of continuous operation for a time period ranging from about 8to about 24 hours per day.

Clause 86: They system of any of clauses 80 to 85, wherein the pump isconfigured to provide intermittent negative pressure.

Clause 87: The system of any of clauses 80 to 86, wherein the pump isconfigured to apply negative pressure independently to each cathetersuch that the pressure in each catheter can be the same or differentfrom the other catheter(s).

Clause 88: The system of any of clauses 80 to 86, wherein the pump isconfigured to alternate between providing negative pressure andproviding positive pressure.

Clause 89: The system of any of clauses 80 to 86, wherein the pump isconfigured to alternate between providing negative pressure andequalizing pressure to atmosphere.

Clause 90: The system of clause 88, wherein the negative pressure isprovided within a range of 5 mmHg to 50 mmHg, and/or wherein thepositive pressure is provided within a range of 5 mmHg to 20 mmHg.

Clause 91: The system of any of clauses 80 to 90, wherein the pump isconfigured to alternate between two or more different pressure levels.

Clause 92: The system of clause 91, wherein the pump is configured toadjust the pressure levels at a regular or irregular frequency based, atleast in part, on a predetermined algorithm.

Clause 93: The system of clause 92, wherein the predetermined algorithmis based in part on demographic data and/or patient-specific variables.

Clause 94: The system of clause 93, wherein the demographic data and/orpatient-specific variables comprise one or more of anatomical, genetic,physiological, and pathophysiological factors.

Clause 95: The system of clause 92, wherein the predetermined algorithmis based, in part, on continuously or non-continuously changing patientvalues, the patient values comprising one or more of urine output rate,peristaltic activity of renal and/or urological system, heart rate,cardiac output, blood pressure, respiration rate, renal blood flow,renal plasma flow, and biomarkers.

Clause 96: A method for extracting urine from a ureter and/or kidney ofa patient for effecting interstitial pressure in the kidney, the methodcomprising: positioning a distal end of a catheter at a fluid collectionposition within a patient's ureter and/or kidney, the cathetercomprising a tube defining a drainage lumen and comprising a helicalretention portion and a plurality of drainage ports; inducing a negativepressure within a drainage lumen of the catheter; and extracting urineby drawing urine through the drainage ports into the drainage lumen,thereby altering interstitial pressure within the patient's kidney.

Clause 97: The method of clause 96, wherein positioning the cathetercomprises deploying the catheter by expanding the helical retentionportion at the fluid collection position.

Clause 98: The method of clause 96 or clause 97, further comprisingpositioning a distal end of the bladder catheter in the patient'sbladder and deploying an anchor within the bladder, such that the anchoressentially or fully seals the urethral sphincter of the bladder.

Clause 99: The method of clause 98, wherein positioning the bladdercatheter in the bladder comprises advancing the bladder catheter over aguidewire used for positioning of the ureteral catheter.

Clause 100: A method of inhibiting kidney damage by application ofnegative pressure to decrease interstitial pressure within tubules ofthe medullar region to facilitate urine output and to prevent venouscongestion-induced nephron hypoxia in the medulla of the kidney, themethod comprising: deploying a ureteral catheter in the ureter and/orkidney of a patient such that flow of urine from the ureter and/orkidney is not prevented by occlusion of the ureter and/or kidney by thedeployed catheter; and applying negative pressure to the ureter and/orkidney through the catheter for a period of time sufficient tofacilitate urine output from the kidney.

Clause 101: The method of clause 100, further comprising positioning abladder catheter in the patient's bladder, such that an anchor of thebladder catheter essentially or fully seals the urethral sphincter ofthe bladder.

Clause 102: The method of clause 101, further comprising causingdrainage of urine from the bladder through the bladder catheter for aperiod of time.

Clause 103: The method of clause 100, wherein deploying the cathetercomprises accessing the ureter and/or kidney through an incision ororifice other than the urethral orifice.

Clause 104: A method for treatment of acute kidney injury due to venouscongestion, the method comprising: deploying a ureteral catheter in theureter and/or kidney of a patient such that flow of urine from theureter and/or kidney is not prevented by occlusion of the ureter and/orkidney; and applying negative pressure to the ureter and/or kidneythrough the catheter for a period of time sufficient to treat acutekidney injury due to venous congestion.

Clause 105: A method for treatment of NYHA Class III and/or Class IVheart failure through reduction of venous congestion in the kidney(s),the method comprising: deploying a ureteral catheter in the ureterand/or kidney of a patient such that flow of urine from the ureterand/or kidney is not prevented by occlusion of the ureter and/or kidney;and applying negative pressure to the ureter and/or kidney through thecatheter for a period of time sufficient to treat NYHA Class III and/orClass IV heart failure.

Clause 106: A method for treatment of NYHA Class II, Class III, and/orClass IV heart failure through reduction of venous congestion in thekidney(s), the method comprising: deploying a catheter in a bladder of apatient such that flow of urine into the bladder from a ureter and/orkidney is not prevented by occlusion; and applying negative pressure tothe bladder through the catheter for a period of time sufficient totreat NYHA Class II, Class III, and/or Class IV heart failure.

Clause 107: A method for treatment of Stage 4 and/or Stage 5 chronickidney disease through reduction of venous congestion in the kidney(s),the method comprising: deploying a ureteral catheter in a ureter and/orkidney of a patient such that flow of urine from the ureter and/orkidney is not prevented by occlusion of the ureter and/or kidney; andapplying negative pressure to the ureter and/or kidney through thecatheter for a period of time sufficient to treat Stage 4 and/or Stage 5chronic kidney disease.

Clause 108: A method for treatment of Stage 3, Stage 4, and/or Stage 5chronic kidney disease through reduction of venous congestion in thekidney(s), the method comprising: deploying a catheter in a bladder of apatient such that flow of urine from a ureter and/or kidney is notprevented by occlusion; and applying negative pressure to the bladderthrough the catheter for a period of time sufficient to treat Stage 3,Stage 4, and/or Stage 5 chronic kidney disease.

Clause 109: A ureteral catheter, comprising: a drainage lumen comprisinga proximal portion configured to be positioned in at least a portion ofa patient's urethra and a distal portion configured to be positioned ina patient's ureter and/or kidney, the distal portion comprising a coiledretention portion, the coiled retention portion comprising: at least afirst coil having a first diameter; at least a second coil having asecond diameter, the first diameter being less than the second diameter;and one or more perforations on a sidewall of the drainage lumen forpermitting fluid flow into the drainage lumen, wherein, prior toinsertion into a patient's urinary tract, a portion of the drainagelumen that is proximal to the retention portion defines a straight orcurvilinear central axis, and wherein, when deployed, the first coil andthe second coil of the retention portion extend about an axis of theretention portion that is at least partially coextensive with thestraight or curvilinear central axis of the portion of the drainagelumen.

Clause 110: The ureteral catheter of clause 109, wherein the axis of theretention portion is curved relative to the central axis of the drainagelumen.

Clause 111: The ureteral catheter of clause 109 or clause 110, whereinat least a portion of the axis of the retention portion extends at anangle from the central axis ranging from about 15 degrees to about 75degrees.

Clauses 112: The ureteral catheter of any of clauses 109 to 111, whereinthe catheter is transitionable between a contracted configuration forinsertion into the patient's ureter and a deployed configuration fordeployment within the ureter.

Clause 113: The ureteral catheter of any of clauses 109 to 112, whereinthe retention portion further comprises a third coil extending about theaxis of the retention portion, the third coil having a diameter greaterthan or equal to either the first diameter or the second diameter.

Clause 114: The ureteral catheter of any of clauses 109 to 113, wherein,the retention portion of the drainage lumen comprises a sidewallcomprising a radially inwardly facing side and a radially outwardlyfacing side, and wherein a total surface area of perforations on theradially inwardly facing side is greater than a total surface area ofperforations on the radially outwardly facing side.

Clause 115: The ureteral catheter of any of clauses 109 to 114, wherein,the retention portion of the drainage lumen comprises a sidewallcomprising a radially inwardly facing side and a radially outwardlyfacing side, and wherein the one or more perforations are disposed onthe radially inwardly facing side, and wherein the radially outwardlyfacing side is essentially free of perforations.

Cause 116: The ureteral catheter of clause any of clauses 109 to 116,wherein the drainage lumen is formed, at least in part, from one or moreof copper, silver, gold, nickel-titanium alloy, stainless steel,titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene(PTFE), latex, and silicone.

Clause 117: The ureteral catheter of any of clauses 109 to 116, whereinthe retention portion of the drainage lumen further comprises an opendistal end for permitting fluid flow into the drainage lumen.

Clause 118: The ureteral catheter of any of clauses 109 to 117, whereineach of the one or more perforations has a diameter of about 0.7 to 0.9mm.

Clause 119: The ureteral catheter of any of clauses 109 to 118, whereinthe first diameter is about 8 mm to 10 mm and the second dimeter isabout 16 mm to 20 mm.

Clause 120: A system for inducing negative pressure in a portion of aurinary tract of a patient, the system comprising: at least one urinecollection catheter comprising a drainage lumen comprising a proximalportion configured to be positioned in at least a portion of a patient'surethra and a distal portion configured to be positioned in a patient'sureter and/or kidney, the distal portion comprising a coiled retentionportion, the coiled retention portion comprising: at least a first coilhaving a first diameter; at least a second coil having a seconddiameter, the first diameter being less than the second diameter; andone or more perforations on a sidewall of the drainage lumen forpermitting fluid flow into the drainage lumen, wherein, prior toinsertion into a patient's urinary tract, a portion of the drainagelumen that is proximal to the retention portion defines a straight orcurvilinear central axis, and wherein, when deployed, the first coil andthe second coil of the retention portion extend about an axis of theretention portion that is at least partially coextensive with thestraight or curvilinear central axis of the portion of the drainagelumen; and a pump in fluid communication with the drainage lumen of theat least one ureteral catheter, the pump being configured for inducing anegative pressure in a portion of the urinary tract of the patient todraw fluid through the drainage lumen of the ureteral catheter.

Clause 121: The system of clause 120, further comprising: one or moresensors in fluid communication with the drainage lumen, the one or moresensors being configured to determine information comprising at leastone of capacitance, analyte concentration, and temperature of urinewithin the respective drainage lumen; and a controller comprisingcomputer readable memory including programming instructions that, whenexecuted, cause the controller to: receive the information from the oneor more sensors and adjust an operating parameter of the pump based, atleast in part, on the information received from the one or more sensorsto increase or decrease vacuum pressure in the drainage lumen of the atleast one ureteral catheter to adjust flow of urine through the drainagelumen.

Clause 122: The system of clause 120 or clause 121, further comprising adata transmitter in communication with the controller, the datatransmitter being configured to provide the information from the one ormore sensors to an external source.

Clause 123: The system of any of clauses 120 to 122, wherein the pumpprovides a sensitivity of 10 mmHg or less.

Clause 124: The system of any of clauses 120 to 122, wherein the pump isconfigured to alternate between providing negative pressure andproviding positive pressure.

Clause 125: The system of clause 124, wherein the negative pressure isprovided within a range of 5 mmHg to 50 mmHg, and wherein the positivepressure is provided within a range of 5 mmHg to 20 mmHg.

Clause 126: A method of inhibiting kidney damage by application ofnegative pressure to decrease interstitial pressure within tubules ofthe medullar region to facilitate urine output and to prevent venouscongestion-induced nephron hypoxia in the medulla of the kidney, themethod comprising: deploying a ureteral catheter in the ureter and/orkidney of a patient such that flow of urine from the ureter and/orkidney is not prevented by occlusion of the ureter and/or kidney by thedeployed catheter; and applying negative pressure to the ureter and/orkidney through the catheter for a period of time sufficient tofacilitate urine output from the kidney, wherein the ureteral cathetercomprises a drainage lumen comprising a proximal portion configured tobe positioned in at least a portion of a patient's urethra and a distalportion configured to be positioned in a patient's ureter and/or kidney,the distal portion comprising a coiled retention portion, the coiledretention portion comprising: at least a first coil having a firstdiameter; at least a second coil having a second diameter, the firstdiameter being less than the second diameter; and one or moreperforations on a sidewall of the drainage lumen for permitting fluidflow into the drainage lumen, wherein, prior to deployment, a portion ofthe drainage lumen that is proximal to the retention portion defines astraight or curvilinear central axis, and wherein, upon deployment, thefirst coil and the second coil of the retention portion extend about anaxis of the retention portion that is at least partially coextensivewith the straight or curvilinear central axis of the portion of thedrainage lumen.

Clause 127: The method of clause 126, further comprising, uponapplication of negative pressure to the ureter and/or kidney, extractingurine by drawing urine through the one or more perforations into thedrainage lumen, thereby altering interstitial pressure within thepatient's kidney.

Clause 128: The method of clause 126 or clause 127, wherein applicationof negative pressure to the ureter and/or kidney through the catheter isprovided for a period of time sufficient to treat acute kidney injurydue to venous congestion.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and characteristics of the present disclosure,as well as the methods of operation and functions of the relatedelements of structures and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limit of the invention.

Further features and other examples and advantages will become apparentfrom the following detailed description made with reference to thedrawings in which:

FIG. 1 is a schematic drawing of an indwelling portion of a urinecollection assembly deployed in a urinary tract of a patient, accordingto an example of the present invention;

FIG. 2A is a perspective view of an exemplary ureteral catheteraccording to an example of the disclosure;

FIG. 2B is a front view of the ureteral catheter of FIG. 2A;

FIG. 3A is a schematic drawing of an example of a retention portion fora ureteral catheter according to an example of the present invention;

FIG. 3B is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 3C is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 3D is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 3E is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 4A is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 4B is a schematic drawing of a cross-sectional view of a portion ofthe retention portion of FIG. 4A, taken along lines B-B of FIG. 4A;

FIG. 5A is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 5B is a schematic drawing of a portion of a cross-sectional view ofthe retention portion of FIG. 5A, taken along lines B-B of FIG. 5A;

FIG. 6 is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 7 is a schematic drawing of a cross section of another example of aretention portion for a ureteral catheter according to an example of thepresent invention;

FIG. 8 is a schematic drawing of another example of a retention portionfor a ureteral catheter according to an example of the presentinvention;

FIG. 9A is a schematic drawing of another example of a urine collectionassembly according to an example of the present invention;

FIG. 9B is a partial schematic drawing taken along section 9B-9B of thebladder anchor portion of the assembly of FIG. 9A;

FIG. 10A is a schematic drawing of another example of a urine collectionassembly according to an example of the present invention;

FIG. 10B is a schematic drawing taken along section 10B-10B of thebladder anchor portion of the assembly of FIG. 10A;

FIG. 11A is a schematic drawing of a urine collection assembly accordingto an example of the present invention;

FIG. 11B is a schematic drawing taken along section 11B-11B of a bladderanchor portion of the assembly of FIG. 11A;

FIG. 12A is a schematic drawing of another bladder anchor portion of aurine collection assembly according to an example of the disclosure;

FIG. 12B is a schematic drawing of a cross section of a bladder catheterof a urine collection assembly, taken along line C-C of FIG. 12A;

FIG. 12C is a schematic drawing of a cross section of another example ofa bladder catheter of a urine collection assembly;

FIG. 13 is a schematic drawing of another example of a bladder anchorportion of a urine collection assembly according to an example of thepresent disclosure;

FIG. 14 is a schematic drawing of another example of a bladder anchorportion of a urine collection assembly according to an example of thepresent disclosure;

FIG. 15 is a schematic drawing of another example of a bladder anchorportion of a urine collection assembly configured to be deployed in thepatient's bladder and urethra according to an example of the presentinvention;

FIG. 16 is a schematic drawing of another example of a bladder anchorportion of a urine collection assembly according to an example of thepresent invention;

FIG. 17A is an exploded perspective view of a connector for a urinecollection assembly according to an example of the disclosure;

FIG. 17B is a cross-sectional view of a portion of the connector of FIG.17A;

FIG. 17C is a schematic drawing of a connector for a urine collectionassembly according to an example of the disclosure;

FIG. 18A is a flow chart illustrating a process for insertion anddeployment of a ureteral catheter or urine collection assembly accordingto an example of the present invention;

FIG. 18B is a flow chart illustrating a process for applying negativepressure using a ureteral catheter or urine collection assemblyaccording to an example of the present invention;

FIG. 19 is a schematic drawing of a system for inducing negativepressure to the urinary tract of a patient according to an example ofthe present invention;

FIG. 20A is a plan view of a pump for use with the system of FIG. 19according to an example of the present invention;

FIG. 20B is a side elevation view of the pump of FIG. 20A;

FIG. 21 is a schematic drawing of an experimental set-up for evaluatingnegative pressure therapy in a swine model;

FIG. 22 is a graph of creatinine clearance rates for tests conductedusing the experimental set-up shown in FIG. 21;

FIG. 23A is a low magnification photomicrograph of kidney tissue from acongested kidney treated with negative pressure therapy;

FIG. 23B is a high magnification photomicrograph of the kidney tissueshown in FIG. 23A;

FIG. 23C is a low magnification photomicrograph of kidney tissue from acongested and untreated (e.g., control) kidney; and

FIG. 23D is a high magnification photomicrograph of the kidney tissueshown in FIG. 23C.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the singular form of “a”, “an”, and “the” include pluralreferents unless the context clearly states otherwise.

As used herein, the terms “right”, “left”, “top”, and derivativesthereof shall relate to the invention as it is oriented in the drawingfigures. The term “proximal” refers to the portion of the catheterdevice that is manipulated or contacted by a user and/or to a portion ofan indwelling catheter nearest to the urinary tract access site. Theterm “distal” refers to the opposite end of the catheter device that isconfigured to be inserted into a patient and/or to the portion of thedevice that is inserted farthest into the patient's urinary tract.However, it is to be understood that the invention can assume variousalternative orientations and, accordingly, such terms are not to beconsidered as limiting. Also, it is to be understood that the inventioncan assume various alternative variations and stage sequences, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices and processes illustrated in the attacheddrawings, and described in the following specification, are examples.Hence, specific dimensions and other physical characteristics related tothe embodiments disclosed herein are not to be considered as limiting.

For the purposes of this specification, unless otherwise indicated, allnumbers expressing quantities of ingredients, reaction conditions,dimensions, physical characteristics, and so forth used in thespecification and claims are to be understood as being modified in allinstances by the term “about.” Unless indicated to the contrary, thenumerical parameters set forth in the following specification andattached claims are approximations that can vary depending upon thedesired properties sought to be obtained by the present invention.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the invention are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements.

Also, it should be understood that any numerical range recited herein isintended to include all sub-ranges subsumed therein. For example, arange of “1 to 10” is intended to include any and all sub-ranges betweenand including the recited minimum value of 1 and the recited maximumvalue of 10, that is, all subranges beginning with a minimum value equalto or greater than 1 and ending with a maximum value equal to or lessthan 10, and all subranges in between, e.g., 1 to 6.3, or 5.5 to 10, or2.7 to 6.1.

As used herein, the terms “communication” and “communicate” refer to thereceipt or transfer of one or more signals, messages, commands, or othertype of data. For one unit or component to be in communication withanother unit or component means that the one unit or component is ableto directly or indirectly receive data from and/or transmit data to theother unit or component. This can refer to a direct or indirectconnection that can be wired and/or wireless in nature. Additionally,two units or components can be in communication with each other eventhough the data transmitted can be modified, processed, routed, and thelike, between the first and second unit or component. For example, afirst unit can be in communication with a second unit even though thefirst unit passively receives data, and does not actively transmit datato the second unit. As another example, a first unit can be incommunication with a second unit if an intermediary unit processes datafrom one unit and transmits processed data to the second unit. It willbe appreciated that numerous other arrangements are possible.

Fluid retention and venous congestion are central problems in theprogression to advanced renal disease. Excess sodium ingestion coupledwith relative decreases in excretion leads to isotonic volume expansionand secondary compartment involvement. In some examples, the presentinvention is generally directed to devices and methods for facilitatingdrainage of urine or waste from the bladder, ureter, and/or kidney(s) ofa patient. In some examples, the present invention is generally directedto devices and methods for inducing a negative pressure in the bladder,ureter, and/or kidney(s) of a patient. While not intending to be boundby any theory, it is believed that applying a negative pressure to thebladder, ureter, and/or kidney(s) can offset the medullary nephrontubule re-absorption of sodium and water in some situations. Offsettingre-absorption of sodium and water can increase urine production,decrease total body sodium, and improve erythrocyte production. Sincethe intra-medullary pressures are driven by sodium and, therefore,volume overload, the targeted removal of excess sodium enablesmaintenance of volume loss. Removal of volume restores medullaryhemostasis. Normal urine production is 1.48-1.96 L/day (or 1-1.4ml/min).

Fluid retention and venous congestion are also central problems in theprogression of prerenal Acute Kidney Injury (AKI). Specifically, AKI canbe related to loss of perfusion or blood flow through the kidney(s).Accordingly, in some examples, the present invention facilitatesimproved renal hemodynamics and increases urine output for the purposeof relieving or reducing venous congestion. Further, it is anticipatedthat treatment and/or inhibition of AKI positively impacts and/orreduces the occurrence of other conditions, for example, reduction orinhibition of worsening renal function in patients with NYHA Class IIIand/or Class IV heart failure. Classification of different levels ofheart failure are described in The Criteria Committee of the New YorkHeart Association, (1994), Nomenclature and Criteria for Diagnosis ofDiseases of the Heart and Great Vessels, (9th ed.), Boston: Little,Brown & Co. pp. 253-256, the disclosure of which is incorporated byreference herein in its entirety. Reduction or inhibition of episodes ofAKI and/or chronically decreased perfusion may also be a treatment forStage 4 and/or Stage 5 chronic kidney disease. Chronic kidney diseaseprogression is described in National Kidney Foundation, K/DOQI ClinicalPractice Guidelines for Chronic Kidney Disease: Evaluation,Classification and Stratification. Am. J. Kidney Dis. 39:S1-S266, 2002(Suppl. 1), the disclosure of which is incorporated by reference hereinin its entirety.

With reference to FIG. 1, the urinary tract comprises a patient's rightkidney 2 and left kidney 4. As discussed above, the kidneys 2, 4 areresponsible for blood filtration and clearance of waste compounds fromthe body through urine. Urine produced by the right kidney 2 and theleft kidney 4 is drained into a patient's bladder 10 through tubules,namely a right ureter 6 and a left ureter 8. For example, urine may beconducted through the ureters 6, 8 by peristalsis of the ureter walls,as well as by gravity. The ureters 6, 8 enter the bladder 10 through aureter orifice or opening 16. The bladder 10 is a flexible andsubstantially hollow structure adapted to collect urine until the urineis excreted from the body. The bladder 10 is transitionable from anempty position (signified by reference line E) to a full position(signified by reference line F). Normally, when the bladder 10 reaches asubstantially full state, urine is permitted to drain from the bladder10 to a urethra 12 through a urethral sphincter or opening 18 located ata lower portion of the bladder 10. Contraction of the bladder 10 can beresponsive to stresses and pressure exerted on a trigone region 14 ofthe bladder 10, which is the triangular region extending between theureteral openings 16 and the urethral opening 18. The trigone region 14is sensitive to stress and pressure, such that as the bladder 10 beginsto fill, pressure on the trigone region 14 increases. When a thresholdpressure on the trigone region 14 is exceeded, the bladder 10 begins tocontract to expel collected urine through the urethra 12.

Exemplary Ureteral Catheters:

As shown in FIG. 1, a urine collection assembly 100 including ureteralcatheters 112, 114 configured to be positioned within the urinary tractof a patient is illustrated. For example, distal ends 120, 121 of theureteral catheters 112, 114 can be configured to be deployed in thepatient's ureters 2, 4 and, in particular, in a renal pelvis 20, 21 areaof the kidneys 6, 8.

In some examples, the urine collection assembly 100 can comprise twoseparate ureteral catheters, such as a first catheter 112 disposed in oradjacent to the renal pelvis 20 of the right kidney 2 and a secondcatheter 114 disposed in or adjacent to the renal pelvis 21 of the leftkidney 4. The catheters 112, 114 can be separate for their entirelengths, or can be held in proximity to one another by a clip, ring,clamp, or other type of connection mechanism (e.g., connector 150) tofacilitate placement or removal of the catheters 112, 114. In someexamples, catheters 112, 114 can merge or be connected together to forma single drainage lumen. In other examples, the catheters 112, 114 canbe inserted through or enclosed within another catheter, tube, or sheathalong portions or segments thereof to facilitate insertion andretraction of the catheters 112, 114 from the body. For example, abladder catheter 116 can be inserted over and/or along the sameguidewire as the ureteral catheters 112, 114, thereby causing theureteral catheters 112, 114 to extend from the distal end of the bladdercatheter 116.

With reference to FIGS. 1, 2A, and 2B, an exemplary ureteral catheter112 can comprise at least one elongated body or tube 122, the interiorof which defines or comprises one or more drainage channel(s) orlumen(s), such as drainage lumen 124. The tube 122 size can range fromabout 1 Fr to about 9 Fr (French catheter scale). In some examples, thetube 122 can have an external diameter ranging from about 0.33 to about3 mm, and an internal diameter ranging from about 0.165 to about 2.39mm. In one preferable example, the tube 122 is 6 Fr and has an outerdiameter of 2.0±0.1 mm. The length of the tube 122 can range from about30 cm to about 120 cm depending on the age (e.g., pediatric or adult)and gender of the patient.

The tube 122 can be formed from a flexible and/or deformable material tofacilitate advancing and/or positioning the tube 122 in the bladder 10and ureters 6, 8 (shown in FIG. 1). The catheter material should beflexible and soft enough to avoid or reduce irritation of the renalpelvis and ureter, but should be rigid enough that the tube 122 does notcollapse when the renal pelvis or other portions of the urinary tractexert pressure on the exterior of the tube 122, or when the renal pelvisand/or ureter are drawn against the tube 122 during inducement ofnegative pressure. For example, the tube 122 can be formed frommaterials including biocompatible polymers, polyvinyl chloride,polytetrafluoroethylene (PTFE) such as Teflon®, silicon coated latex, orsilicon. In one preferable example, the tube 122 is formed from athermoplastic polyurethane. At least a portion or all of the catheter112, such as the tube 122, can be coated with a hydrophilic coating tofacilitate insertion and/or removal, and/or to enhance comfort. In someexamples, the coating is a hydrophobic and/or lubricious coating. Forexample, suitable coatings can comprise ComfortCoat® hydrophilic coatingwhich is available from Koninklijke DSM N.V. or hydrophilic coatingscomprising polyelectrolyte(s) such as are disclosed in U.S. Pat. No.8,512,795, which is incorporated herein by reference.

In some examples, the tube 122 can comprise: a distal portion 118 (e.g.,a portion of the tube 122 configured to be positioned in the ureter 6, 8and renal pelvis 20, 21); a middle portion 126 (e.g., a portion of thetube 122 configured to extend from the distal portion through theureteral openings 16 into the patient's bladder 10 and urethra 12); anda proximal portion 128 (e.g., a portion of the tube 122 extending fromthe urethra 12 to an external fluid collection container and/or pumpassembly). In one preferred example, the combined length of the proximalportion 128 and the middle portion 126 of the tube 122 is about 54±2 cm.In some examples, the tube 122 terminates in another indwelling catheterand/or drainage lumen, such as in a drainage lumen of the bladdercatheter 116. In that case, fluid drains from the proximal end of theureteral catheter 112, 114 and is directed from the body through theadditional indwelling catheter and/or drainage lumen.

Exemplary Ureteral Retention Portions:

With continued reference to FIGS. 1, 2A, and 2B, the distal portion 118of the ureteral catheter 112 comprises a retention portion 130 formaintaining the distal end 120 of the catheter 112 at a desired fluidcollection position proximate to or within the renal pelvis 20, 21 ofthe kidney 2, 4. In some examples, the retention portion 130 isconfigured to be flexible and bendable to permit positioning of theretention portion 130 in the ureter and/or renal pelvis. The retentionportion 130 is desirably sufficiently bendable to absorb forces exertedon the catheter 112 and to prevent such forces from being translated tothe ureters. For example, if the retention portion 130 is pulled in theproximal direction P (shown in FIG. 3A) toward the patient's bladder,the retention portion 130 can be sufficiently flexible to begin tounwind or be straightened so that it can be drawn through the ureter.Similarly, when the retention portion 130 can be reinserted into therenal pelvis or other suitable region within the ureter, it can bebiased to return to its deployed configuration.

In some examples, the retention portion 130 is integral with the tube122. In that case, the retention portion 130 can be formed by impartinga bend or curl to the catheter body 122 that is sized and shaped toretain the catheter at a desired fluid collection location. Suitablebends or coils can include a pigtail coil, corkscrew coil, and/orhelical coil. For example, the retention portion 130 can comprise one ormore radially and longitudinally extending helical coils configured tocontact and passively retain the catheter 112 within the ureter 6, 8proximate to or within the renal pelvis 20, 21. In other examples, theretention portion 130 is formed from a radially flared or taperedportion of the catheter body 122. For example, the retention portion 130can further comprise a fluid collecting portion, as shown in FIGS. 4Aand 4B, such as a tapered or funnel-shaped inner surface 186. In otherexamples, the retention portion 130 can comprise a separate elementconnected to and extending from the catheter body or tube 122.

The retention portion 130 can further comprise one or more perforatedsections, such as drainage holes or ports 132 (shown in FIGS. 3A-3E). Adrainage port can be located, for example, at the open distal end 120,121 of the tube 122. In other examples, perforated sections and/ordrainage ports 132 are disposed along the sidewall of the distal portion118 of the catheter tube 122. The drainage ports or holes can be usedfor assisting in fluid collection. In other examples, the retentionportion 130 is solely a retention structure and fluid collection and/orimparting negative pressure is provided by structures at other locationson the catheter tube 122.

Referring now to FIGS. 2A, 2B, and 3A-3E, exemplary retention portions130 comprising a plurality of helical coils, such as one or more fullcoils 184 and one or more half or partial coils 183, are illustrated.The retention portion 130 is capable of moving between a contractedposition and the deployed position with the plurality of helical coils.For example, a substantially straight guidewire can be inserted throughthe retention portion 130 to maintain the retention portion 130 in asubstantially straight contracted position. When the guidewire isremoved, the retention portion 130 can transition to its coiledconfiguration. In some examples, the coils 183, 184 extend radially andlongitudinally from the distal portion 118 of the tube 122. Withspecific reference to FIGS. 2A and 2B, in a preferred exemplaryembodiment, the retention portion 130 comprises two full coils 184 andone half coil 183. The outer diameter of the full coils 184, shown byline D1, can be about 18±2 mm. The half coil 183 diameter D2 can beabout 14 mm. The coiled retention portion 130 has a height H of about16±2 mm. The retention portion 130 can further comprise the one or moredrainage holes 132 (shown in FIGS. 3A-3E) configured to draw fluid intoan interior of the catheter tube 122. In some examples, the retentionportion 130 can comprise six drainage holes, plus an additional hole atthe distal tip 120 of the retention portion. The diameter of each of thedrainage holes 132 (shown in FIGS. 3A-3E) can range from about 0.7 mm to0.9 mm and, preferably, is about 0.83±0.01 mm. The distance betweenadjacent drainage holes 132, specifically the linear distance betweendrainage holes 132 when the coils are straightened, can be about22.5±2.5 mm.

As shown in FIGS. 3A-3E, in another exemplary embodiment, the distalportion 118 of the drainage lumen proximal to the retention portion 130defines a straight or curvilinear central axis L. In some examples, atleast a half or first coil 183 and a full or second coil 184 of theretention portion 130 extend about an axis A of the retention portion130. The first coil 183 initiates or begins at a point where the tube122 is bent at an angle α ranging from about 15 degrees to about 75degrees from the central axis L, as indicated by angle α, and preferablyabout 45 degrees. As shown in FIGS. 3A and 3B, prior to insertion in thebody, the axis A can be coextensive with the longitudinal central axisL. In other examples, as shown in FIGS. 3C-3E, prior to insertion in thebody, the axis A extends from and is curved or angled, for example atangle (3, relative to the central longitudinal axis L.

In some examples, multiple coils 184 can have the same inner and/orouter diameter D and height H2. In that case, the outer diameter D1 ofthe coils 184 may range between 10 mm and 30 mm. The height H2 betweencoils 184 may be about 3 mm to 10 mm.

In other examples, the retention portion 130 is configured to beinserted in the tapered portion of the renal pelvis. For example, theouter diameter D1 of the coils 184 can increase toward the distal end120 of the tube 122, resulting in a helical structure having a taperedor partially tapered configuration. For example, the distal or maximumouter diameter D1 of the tapered helical portion ranges from about 10 mmto about 30 mm, which corresponds to the dimensions of the renal pelvis.The height H2 of the retention portion 130 ranges from about 10 mm toabout 30 mm.

In some examples, the outer diameter D1 and/or height H2 of the coils184 can vary in a regular or irregular fashion. For example, the outerdiameter D1 of coils or height H2 between coils can increase or decreaseby a regular amount (e.g., about 10% to about 25% between adjacent coils184). For example, for a retention portion 130 having three coils (asshown, for example, in FIGS. 3A and 3B) an outer diameter D3 of aproximal-most coil or first coil 183 can be about 6 mm to 18 mm, anouter diameter D2 of a middle coil or second coil 185 can be about 8 mmto about 24 mm, and an outer diameter D1 of a distal-most or third coil187 can be between about 10 mm and about 30 mm.

The retention portion 130 can further comprise the drainage ports 132 orholes disposed on or through the sidewall of the catheter tube 122 on oradjacent to the retention portion 130 to permit urine waste to flow fromthe outside of the catheter tube 122 to the inside of the catheter tube122. The position and size of the drainage ports 132 can vary dependingupon the desired flow rate and configuration of the retention portion.The diameter of the drainage ports 132 can range from about 0.005 mm toabout 1.0 mm. The spacing between the drainage ports 132 can range fromabout 1.5 mm to about 5 mm. The drainage ports 132 can be spaced in anyarrangement, for example, linear or offset. In some examples, thedrainage ports 132 can be non-circular, and can have a surface area ofabout 0.00002 to 0.79 mm².

In some examples, as shown in FIG. 3A, the drainage ports 132 arelocated around the entire periphery of the sidewall of the catheter tube122 to increase an amount of fluid that can be drawn into the drainagelumen 124 (shown in FIGS. 1, 2A, and 2B). In other examples, as shown inFIGS. 3B-3E, the drainage ports 132 can be disposed essentially only oronly on the radially inwardly facing side of the coils 184 to preventocclusion or blockage of the drainage ports 132, and the outwardlyfacing side of the coils may be essentially free of drainage ports 132or free of drainage ports 132. For example, when negative pressure isinduced in the ureter and/or renal pelvis, mucosal tissue of the ureterand/or kidney may be drawn against the retention portion 130 and mayocclude some drainage ports 132 on the outer periphery of the retentionportion 130. Drainage ports 132 located on the radially inward side ofthe retention structure would not be appreciably occluded when suchtissues contact the outer periphery of the retention portion 130.Further, risk of injury to the tissues from pinching or contact with thedrainage ports 132 can be reduced or ameliorated.

With reference to FIGS. 3C and 3D, other examples of ureteral catheters112 having a retention portion 130 comprising a plurality of coils areillustrated. As shown in FIG. 3C, the retention portion 130 comprisesthree coils 184 extending about the axis A. The axis A is a curved arcextending from the central longitudinal axis L of the portion of thedrainage lumen 181 proximal to the retention portion 130. The curvatureimparted to the retention portion 130 can be selected to correspond tothe curvature of the renal pelvis, which comprises a cornucopia-shapedcavity.

As shown in FIG. 3D, in another exemplary embodiment, the retentionportion 130 can comprise two coils 184 extending about an angled axis A.The angled axis A extends at an angle from a central longitudinal axisL, and is angled, as shown by angle β, relative to an axis generallyperpendicular to the central axis L of the portion of the drainagelumen. The angle β can range from about 15 to about 75 degrees (e.g.,about 105 to about 165 degrees relative to the central longitudinal axisL of the drainage lumen portion of the catheter 112).

FIG. 3E shows another example of a ureteral catheter 112. The retentionportion comprises three helical coils 184 extending about an axis A. Theaxis A is angled, as shown by angle β, relative to the horizontal. As inthe previously-described examples, the angle β can range from about 15to about 75 degrees (e.g., about 105 to about 165 degrees relative tothe central longitudinal axis L of the drainage lumen portion of thecatheter 112).

With reference to FIGS. 4A and 4B, in another example, a retentionportion 130 of a ureteral catheter 112 comprises a catheter tube 122having a widened and/or tapered distal end portion which, in someexamples, is configured to be positioned in the patient's renal pelvisand/or kidney. For example, the retention portion 130 can be afunnel-shaped structure comprising an outer surface 185 configured to bepositioned against the ureter and/or kidney wall and comprising an innersurface 186 configured to direct fluid toward a drainage lumen 124 ofthe catheter 112. The retention portion 130 can comprise a proximal end188 adjacent to the distal end of the drainage lumen 124 and having afirst diameter D1 and a distal end 190 having a second diameter D2 thatis greater than the first diameter D1 when the retention portion 130 isin its deployed position. In some examples, the retention portion 130 istransitionable from a collapsed or compressed position to the deployedposition. For example, the retention portion 130 can be biased radiallyoutward such that when the retention portion 130 is advanced to itsfluid collecting position, the retention portion 130 (e.g., the funnelportion) expands radially outward to the deployed state.

The retention portion 130 of the ureteral catheter 112 can be made froma variety of suitable materials that are capable of transitioning fromthe collapsed state to the deployed state. In one example, the retentionportion 130 comprises a framework of tines or elongated members formedfrom a temperature sensitive shape memory material, such as nitinol. Insome examples, the nitinol frame can be covered with a suitablewaterproof material such as silicon to form a tapered portion or funnel.In that case, fluid is permitted to flow down the inner surface 186 ofthe retention portion 130 and into the drainage lumen 124. In otherexamples, the retention portion 130 is formed from various rigid orpartially rigid sheets or materials bended or molded to form afunnel-shaped retention portion as illustrated in FIGS. 4A and 4B.

In some examples, the retention portion of the ureteral catheter 112 caninclude one or more mechanical stimulation devices 191 for providingstimulation to nerves and muscle fibers in adjacent tissues of theureter(s) and renal pelvis. For example, the mechanical stimulationdevices 191 can include linear or annular actuators embedded in ormounted adjacent to portions of the sidewall of the catheter tube 122and configured to emit low levels of vibration. In some examples,mechanical stimulation can be provided to portions of the ureters and/orrenal pelvis to supplement or modify therapeutic effects obtained byapplication of negative pressure. While not intending to be bound bytheory, it is believed that such stimulation affects adjacent tissuesby, for example, stimulating nerves and/or actuating peristaltic musclesassociated with the ureter(s) and/or renal pelvis. Stimulation of nervesand activation of muscles may produce changes in pressure gradients orpressure levels in surrounding tissues and organs which may contributeto or, in some cases, enhance therapeutic benefits of negative pressuretherapy.

With reference to FIGS. 5A and 5B, according to another example, aretention portion 330 of a ureteral catheter 312 comprises a cathetertube 322 having a distal portion 318 formed in a helical structure 332and an inflatable element or balloon 350 positioned proximal to thehelical structure 332 to provide an additional degree of retention inthe renal pelvis and/or fluid collection location. A balloon 350 can beinflated to pressure sufficient to retain the balloon in the renalpelvis or ureter, but low enough to avoid distending or damaging thesestructures. Suitable inflation pressures are known to those skilled inthe art and are readily discernible by trial and error. As inpreviously-described examples, the helical structure 332 can be impartedby bending the catheter tube 322 to form one or more coils 334. Thecoils 334 can have a constant or variable diameter and height asdescribed above. The catheter tube 322 further comprises a plurality ofdrainage ports 336 disposed on the sidewall of the catheter tube 322 toallow urine to be drawn into the drainage lumen 324 of the catheter tube322 and to be directed from the body through the drainage lumen 324, forexample on the inwardly facing and/or outwardly facing sides of the coil334.

As shown in FIG. 5B, the inflatable element or balloon 350 can comprisean annular balloon-like structure having, for example, a generallyheart-shaped cross section and comprising a surface or cover 352defining a cavity 353. The cavity 353 is in fluid communication with aninflation lumen 354 extending parallel to the drainage lumen 324 definedby the catheter tube 322. The balloon 350 can be configured to beinserted in the tapered portion of the renal pelvis and inflated suchthat an outer surface 356 thereof contacts and rests against an innersurface of the ureter and/or renal pelvis. The inflatable element orballoon 350 can comprise a tapered inner surface 358 extendinglongitudinally and radially inward towards the catheter tube 322. Theinner surface 358 can be configured to direct urine toward the cathetertube 322 to be drawn into the drainage lumen 324. The inner surface 358can also be positioned to prevent fluid from pooling in the ureter, suchas around the periphery of the inflatable element or balloon 350. Theinflatable retention portion or balloon 350 is desirably sized to fitwithin the renal pelvis and can have a diameter ranging from about 10 mmto about 30 mm.

With reference to FIGS. 6 and 7, in some examples, an assembly 400including a ureteral catheter 412 comprising a retention portion 410 isillustrated. The retention portion 410 is formed from a porous and/orsponge-like material that is attached to a distal end 421 of a cathetertube 422. The porous material can be configured to channel and/or absorburine and direct the urine toward a drainage lumen 424 of the cathetertube 422. As shown in FIG. 7, the retention portion 410 can be a porouswedge shaped-structure configured for insertion and retention in thepatient's renal pelvis. The porous material comprises a plurality ofholes and/or channels. Fluid can be drawn through the channels andholes, for example, by gravity or upon inducement of negative pressurethrough the catheter 412. For example, fluid can enter the wedge-shapedretention portion 410 through the holes and/or channels and is drawntoward a distal opening 420 of the drainage lumen 424, for example, bycapillary action, peristalsis, or as a result of the inducement ofnegative pressure in the holes and/or channels. In other examples, asshown in FIG. 7, the retention portion 410 comprises a hollow, funnelstructure formed from the porous sponge-like material. As shown by arrowA, fluid is directed down an inner surface 426 of the funnel structureinto the drainage lumen 424 defined by the catheter tube 422. Also,fluid can enter the funnel structure of the retention portion 410through holes and channels in the porous sponge-like material of asidewall 428. For example, suitable porous materials can includeopen-celled polyurethane foams, such as polyurethane ether. Suitableporous materials can also include laminates of woven or non-woven layerscomprising, for example, polyurethane, silicone, polyvinyl alcohol,cotton, or polyester, with or without antimicrobial additives such assilver, and with or without additives for modifying material propertiessuch as hydrogels, hydrocolloids, acrylic, or silicone.

With reference to FIG. 8, according to another example, a retentionportion 500 of a ureteral catheter 512 comprises an expandable cage 530.The expandable cage 530 comprises one or more longitudinally andradially extending hollow tubes 522. For example, the tubes 522 can beformed from an elastic, shape memory material such as nitinol. The cage530 is configured to transition from a contracted state, for insertionthrough the patient's urinary tract, to a deployed state for positioningin the patient's ureters and/or kidney. The hollow tubes 522 comprise aplurality of drainage ports 534 which can be positioned on the tubes,for example, on radially inward facing sides thereof. The ports 534 areconfigured to permit fluid to flow or be drawn through the ports 534 andinto the respective tubes 522. The fluid drains through the hollow tubes522 into a drainage lumen 524 defined by a catheter body 526 of theureteral catheter 512. For example, fluid can flow along the pathindicated by the arrows 532 in FIG. 8. In some examples, when negativepressure is induced in the renal pelvis, kidneys, and/or ureters,portions of the ureter wall and/or renal pelvis may be drawn against theoutward facing surfaces of the hollow tubes 522. The drainage ports 534are positioned and configured so as not to be appreciably occluded byureteral structures upon application of negative pressure to the uretersand/or kidney.

Exemplary Urine Collection Assembly:

Referring now to FIGS. 1, 9A, and 11A, the urine collection assembly 100further comprises a bladder catheter 116. The distal ends 120, 121 ofthe ureteral catheters 112, 114 can be connected to the bladder catheter116 to provide a single drainage lumen for urine, or the ureteralcatheter(s) can drain via separate tube(s) from the bladder catheter116.

Exemplary Bladder Catheter

The bladder catheter 116 comprises a deployable seal and/or anchor 136for anchoring, retaining, and/or providing passive fixation forindwelling portions of the urine collection assembly 100 and, in someexamples, to prevent premature and/or untended removal of assemblycomponents during use. The anchor 136 is configured to be locatedadjacent to the lower wall of the patient's bladder 10 (shown in FIG. 1)to prevent patient motion and/or forces applied to indwelling catheters112, 114, 116 from translating to the ureters. The bladder catheter 116comprises an interior of which defines a drainage lumen 140 configuredto conduct urine from the bladder 10 to an external urine collectioncontainer 712 (shown in FIG. 19). In some examples, the bladder catheter116 size can range from about 8 Fr to about 24 Fr. In some examples, thebladder catheter 116 can have an external diameter ranging from about2.7 to about 8 mm. In some examples, the bladder catheter 116 can havean internal diameter ranging from about 2.16 to about 6.2 mm. Thebladder catheter 116 can be available in different lengths toaccommodate anatomical differences for gender and/or patient size. Forexample, the average female urethra length is only a few inches, so thelength of a tube 138 can be rather short. The average urethra length formales is longer due to the penis and can be variable. It is possiblethat woman can use bladder catheters 116 with longer length tubes 138provided that the excess tubing does not increase difficulty inmanipulating and/or preventing contamination of sterile portions of thecatheter 116. In some examples, a sterile and indwelling portion of thebladder catheter 116 can range from about 1 inch to 3 inches (for women)to about 20 inches for men. The total length of the bladder catheter 116including sterile and non-sterile portions can be from one to severalfeet.

The catheter tube 138 can comprise one or more drainage ports 142configured to be positioned in the bladder 10 for drawing urine into thedrainage lumen 140. For example, excess urine left in the patient'sbladder 10 during placement of the ureteral catheters 112, 114 isexpelled from the bladder 10 through the ports 142 and drainage lumen140. In addition, any urine that is not collected by the ureteralcatheters 112, 114 accumulates in the bladder 10, and can be conductedfrom the urinary tract through the drainage lumen 140. The drainagelumen 140 may be pressurized to a negative pressure to assist in fluidcollection or may be maintained at atmospheric pressure such that fluidis collected by gravity and/or as a result of partial contraction of thebladder 10. In some examples, the ureteral catheters 112, 114 may extendfrom the drainage lumen 140 of the bladder catheter 116 to facilitateand/or simplify insertion and placement of the ureteral catheters 112,114.

With specific reference to FIG. 1, the deployable seal and/or anchor 136is disposed at or adjacent to a distal end 148 of the bladder catheter116. The deployable anchor 136 is configured to transition between acontracted state for insertion into the bladder 10 through the urethra12 and urethral opening 18 and a deployed state. The anchor 136 isconfigured to be deployed in and seated adjacent to a lower portion ofthe bladder 10 and/or against the urethral opening 18. For example, theanchor 136 can be positioned adjacent to the urethral opening 18 toenhance suction of a negative pressure applied to the bladder 10 or, inthe absence of negative pressure, to partially, substantially, orentirely seal the bladder 10 to ensure that urine in the bladder 10 isdirected through the drainage lumen 140 and to prevent leakage to theurethra 12. For a bladder catheter 116 including an 8 Fr to 24 Frelongated tube 138, the anchor 136 can be about 12 Fr to 32 Fr (e.g.,having a diameter of about 4 mm to about 10.7 mm) in the deployed state,and preferably between about 24 Fr and 30 Fr. A 24 Fr anchor has adiameter of about 8 mm. It is believed that a 24 Fr anchor 136 would bea single size suitable for all or most patients. For a catheter 116 witha 24 Fr anchor 136, a suitable length of the anchor 136 is between about1.0 cm and 2.3 cm, and preferably about 1.9 cm (about 0.75 in).

Exemplary Bladder Anchor Structures:

With specific reference to FIGS. 1, 12A, and 13, an exemplary bladderanchor 136 in the form of an expandable balloon 144 is illustrated. Theexpandable (e.g., inflatable) balloon 144 can be, for example, aspherical balloon of a Foley catheter. The balloon 144 can be about 1.0cm to 2.3 cm in diameter, and preferably about 1.9 cm (0.75 in) indiameter. The balloon 144 is preferably formed from a flexible materialincluding, for example, biocompatible polymers, polyvinyl chloride,polytetrafluoroethylene (PTFE) such as Teflon®, silicon coated latex, orsilicon.

The balloon 144 is in fluid connection with an inflation lumen 146, andis inflated by introducing fluid into the balloon 144. In a deployedstate, the balloon 144 can be a substantially spherical structuremounted to and extending radially outward from the catheter tube 138 ofthe bladder catheter 116 and comprising a central cavity or channel forthe catheter tube 138 to pass through. In some examples, the cathetertube 138 extends through the cavity defined by the balloon 144, suchthat the open distal end 148 of the catheter tube 138 extends distallybeyond the balloon 144 and toward the center of the bladder 10 (shown inFIG. 1). Excess urine collected in the bladder 10 can be drawn into thedrainage lumen 140 through the distal open end 148 thereof.

As shown in FIGS. 1 and 12A, in one example, the ureteral catheters 112,114 extend from the open distal end 148 of the drainage lumen 140. Inanother example, as shown in FIG. 14, the ureteral catheters 112, 114extend through ports 172 or openings disposed on a sidewall of thecatheter tube 138 at a position distal to the balloon 144. The ports 172can be circular or oval shaped. The ports 172 are sized to receive theureteral catheters 112, 114 and, accordingly, can have a diameterranging from about 0.33 mm to about 3 mm. As shown in FIG. 13, inanother example, the bladder catheter 116 is positioned next to theballoon 144, rather than extending through a central cavity defined bythe balloon 144. As in other examples, the ureteral catheters 112, 114extend through ports 172 in the sidewall of the bladder catheter 116 andinto the bladder 10.

With reference to FIG. 12B, a cross-sectional view of the bladdercatheter 116 and ureteral catheter(s) 112, 114 is shown. As shown inFIG. 12B, in one example, the bladder catheter 116 comprises a duallumen catheter with the drainage lumen 140 at a central region thereofand a smaller inflation lumen 146 extending along the periphery of thecatheter tube 138. The ureteral catheters 112, 114 are inserted orenclosed in the central drainage lumen 140. The ureteral catheters 112,114 are single-lumen catheters having a sufficiently narrow crosssection to fit within the drainage lumen 140. In some examples, asdiscussed above, the ureteral catheters 112, 114 extend through theentire bladder catheter 116. In other examples, the ureteral catheters112, 114 terminate in the drainage lumen 140 of the bladder catheter116, either at a position in the patient's ureter 12 or in an externalportion of the drainage lumen 140. As shown in FIG. 12C, in anotherexample, a bladder catheter 116 a is a multi-lumen catheter that definesat least four lumens, namely a first lumen 112 a for conducting fluidfrom the first ureteral catheter 112 (shown in FIG. 1), a second lumen114 a for conducting fluid from the second ureteral catheter 114 (shownin FIG. 1), a third lumen 140 a for drainage of urine from the bladder10 (shown in FIG. 1), and the inflation lumen 146 a for conducting fluidto and from the balloon 144 (shown in FIG. 12A) for inflation andretraction thereof.

As shown in FIG. 15, another example of a catheter balloon 144 for usewith a urine collection assembly 100 is illustrated. In the example ofFIG. 15, the balloon 144 is configured to be positioned partially withinthe patient's bladder 10 and partially within the urethra 12 to providean enhanced bladder seal. A central portion 145 of the balloon 144 isconfigured to be radially contracted by the urethral opening 18, therebydefining a bulbous upper volume configured to be positioned in the lowerportion of the bladder 10 and a bulbous lower volume configured to beposition at the distal portion of the urethra 12. As inpreviously-described examples, the bladder catheter 116 extends througha central cavity defined by the balloon 144 and toward a central portionof the bladder 10 and includes drainage ports 142 for conducting urinefrom the bladder 10 through a drainage lumen 140 of the catheter 116.The drainage ports 142 can be generally circular or oval shaped and canhave a diameter of about 0.005 mm to about 0.5 mm.

With reference again to FIGS. 9A and 9B, another example of a urinecollection assembly 100 including a bladder anchor device 134 isillustrated. The bladder anchor device 134 comprises a bladder catheter116 defining a drainage lumen 140, an inflation lumen 146, and an anchor136, namely, another example of an expandable balloon 144, configured tobe seated in a lower portion of the bladder 10. Unlike in thepreviously-described examples, the ports 142 configured to receive theureteral catheters 112, 114 are disposed proximal to and/or below theballoon 144. The ureteral catheters 112, 114 extend from the ports 142and, as in previously-described examples, extend through the ureteralorifices or openings of the bladder and into the ureters. When theanchor 136 is deployed in the bladder, the ports 142 are disposed in alower portion of the bladder adjacent to the urethral opening. Theureteral catheters 112, 114 extend from the ports 172 and between alower portion of the balloon 144 and the bladder wall. In some examples,the catheters 112, 114 may be positioned to prevent the balloon 144and/or bladder wall from occluding the ports 142 so that excess urinecollected in the bladder can be drawn into the ports 142 to be removedfrom the body.

With reference again to FIGS. 10A and 10B, in another example of a urinecollection assembly 200, an expandable cage 210 anchors the assembly 200in the bladder. The expandable cage 210 comprises a plurality offlexible members 212 or tines extending longitudinally and radiallyoutward from a catheter body 238 of a bladder catheter 216 which, insome examples, can be similar to those discussed above with respect tothe retention portion of the ureteral catheter of FIG. 8. The members212 can be formed from a suitable elastic and shape memory material suchas nitinol. In a deployed position, the members 212 or tines areimparted with a sufficient curvature to define a spherical or ellipsoidcentral cavity 242. The cage 210 is attached to an open distal open end248 of the catheter tube or body 238, to allow access to a drainagelumen 240 defined by the tube or body 238. The cage 210 is sized forpositioning within the lower portion of the bladder and can define adiameter and length ranging from 1.0 cm to 2.3 cm, and preferably about1.9 cm (0.75 in).

In some examples, the cage 210 further comprises a shield or cover 214over distal portions of the cage 210 to prevent or reduce the likelihoodthat tissue, namely, the distal wall of the bladder, will be caught orpinched as a result of contact with the cage 210 or member 212. Morespecifically, as the bladder contracts, the inner distal wall of thebladder comes into contact with the distal side of the cage 210. Thecover 214 prevents the tissue from being pinched or caught, may reducepatient discomfort, and protect the device during use. The cover 214 canbe formed at least in part from a porous and/or permeable biocompatiblematerial, such as a woven polymer mesh. In some examples, the cover 214encloses all or substantially all of the cavity 242. In that case, thecover 214 defines openings suitable for receiving the ureteral catheters112, 114. In some examples, the cover 214 covers only about the distal⅔, about the distal half, or about the distal third portion or anyamount, of the cage 210. In that case, the ureteral catheters 112, 114pass through the uncovered portion of the cage 210.

The cage 210 and cover 214 are transitionable from a contractedposition, in which the members 212 are contracted tightly togetheraround a central portion and/or around the bladder catheter 116 topermit insertion through a catheter or sheath to the deployed position.For example, in the case of a cage 210 constructed from a shape memorymaterial, the cage 210 can be configured to transition to the deployedposition when it is warmed to a sufficient temperature, such as bodytemperature (e.g., 37° C.). In the deployed position, the cage 210 has adiameter D that is preferably wider than the urethral opening, such thatthe cage 210 provides support for the ureteral catheters 112, 114 andprevents patient motion from translating through the ureteral catheters112, 114 to the ureters. When the assembly 200 is deployed in theurinary tract, the ureteral catheter(s) 112, 114 extend from the opendistal end 248 of the bladder catheter 216, past the longitudinallyextending members 212 of the cage 210, and into the bladder.Advantageously, the open (e.g., low profile) arrangement of the members212 or tines facilitates manipulation of the ureteral catheters 112, 114from the bladder catheter 116 and through the bladder. Particularly, theopen arrangement of the members 212 or tines does not obstruct orocclude the distal opening 248 and/or drainage ports of the bladdercatheter 216, making manipulation of the catheters 112, 114 easier toperform.

With reference to FIG. 16, a portion of another example of a urinecollection assembly 100 b is illustrated. The urine collection assembly100 b comprises a first ureteral catheter 112 b and a second ureteralcatheter 114 b. The assembly 100 b does not comprise a separate bladderdrainage catheter as is provided in the previously-described examples.Instead, one of the ureteral catheters 112 b comprises a helical portion127 b formed in the middle portion of the catheter 112 b (e.g., theportion of the catheter configured to be positioned in a lower portionof the patient's bladder). The helical portion 127 b comprises at leastone and preferably two or more coils 176 b. The coils 176 b can beformed by bending a catheter tube 138 b to impart a desired coilconfiguration. A lower coil 178 b of the helical portion 127 b isconfigured to be seated against and/or adjacent to the urethral opening.Desirably, the helical portion 127 b has a diameter D that is largerthan the urethral opening to prevent the helical portion 127 b frombeing drawn into the urethra. In some examples, a port 142 b or openingis disposed in the sidewall of the catheter tube 138 b for connectingthe first ureteral catheter 112 b to the second ureteral catheter 114 b.For example, the second catheter 114 b can be inserted in the port 142 bto form a fluid connection between the first ureteral catheter 112 b andthe second ureteral catheter 114 b. In some examples, the secondcatheter 114 b terminates at a position just inside a drainage lumen 140b of the first catheter 112 b. In other examples, the second ureteralcatheter 114 b is threaded through and/or extends along the length ofthe drainage lumen 140 b of the first catheter 112 b, but is not influid communication with the drainage lumen 140 b.

With reference again to FIGS. 11A and 11B, another exemplary urinecollection assembly 100 comprising a bladder anchor device 134 isillustrated. The assembly 100 includes ureteral catheters 112, 114 and aseparate bladder catheter 116. More specifically, as inpreviously-described examples, the assembly 100 includes the ureteralcatheters 112, 114, each of which comprise a distal portion 118positioned in or adjacent to the right kidney and the left kidney,respectively. The ureteral catheters 112, 114 comprise indwellingportions 118, 126, 128 extending through the ureters, bladder, andurethra. The ureteral catheters 112, 114 further comprise an externalportion 170 extending from the patient's urethra 12 to a pump assemblyfor imparting negative pressure to the renal pelvis and/or kidneys. Theassembly 100 also includes a bladder anchor device 134 comprising abladder catheter 116 and an anchor 136 (e.g., a Foley catheter) deployedin the bladder to prevent or reduce effects of patient motion from beingtranslated to the ureteral catheters 112, 114 and/or ureters. Thebladder catheter 116 extends from the bladder 10, through the urethra,and to a fluid collection container for fluid collection by gravity ornegative pressure drainage. In some examples, an external portion of thetubing extending between a collection vessel 712 and a pump 710 (shownin FIG. 19) can comprise one or more filters for preventing urine and/orparticulates from entering the pump. As in previously-describedexamples, the bladder catheter 116 is provided to drain excess urineleft in the patient's bladder during catheter placement.

Exemplary Connectors and Clamps:

With reference to FIGS. 1, 11A, and 17A-17C, the assembly 100 furthercomprises a manifold or connector 150 for joining the two or more of thecatheters 112, 114, 116 at a position outside the patient's body. Insome examples, the connector 150 can be a clamp, manifold, valve,fastener, or other element of a fluid path set, as is known in the art,for joining a catheter to external flexible tubing. As shown in FIGS.17A and 17B, the manifold or connector 150 comprises a two-piece bodycomprising an inner portion 151 mounted inside an outer housing 153. Theinner portion 151 defines channels for conducting fluid between inflowports 154, 155 and an outflow port 158. The inflow port(s) 154, 155 cancomprise threaded sockets 157 configured to receive proximal portions ofthe catheters 112, 114. Desirably, the sockets 157 are a suitable sizeto securely receive and hold flexible tubing sized between 1 Fr and 9Fr. Generally, a user cinches the sockets 157 around the respectivecatheter tubes 122 by spinning the socket 157 into the ports 154, 155 inthe direction of arrow A1 (shown in FIG. 17B).

Once the catheters 112, 114 are mounted to the connector 150, urineentering the connector 150 through the vacuum inflow ports 154, 155 isdirected through a fluid conduit in the direction of arrow A2 (shown inFIG. 17B) to the vacuum outflow port 158. The vacuum outflow port 158can be connected to the fluid collection container 712 and/or pumpassembly 710 (shown in FIG. 19) by, for example, flexible tubing 166defining a fluid flow path.

With specific reference to FIG. 17C, another exemplary connector 150 canbe configured to connect three or more catheters 112, 114, 116 tooutflow ports 158, 162. The connector 150 can comprise a structure orbody having a distal side 152 comprising two or more vacuum inflow ports154, 155 configured to be connected to proximal ends of the ureteralcatheters 112, 114, and a separate gravity drainage port 156 configuredto connect to the proximal end of the bladder catheter 116. The vacuumports 154, 155 and/or proximal ends of the ureteral catheters 112, 114can comprise a specific configuration to ensure that the ureteralcatheters 112, 114 are connected to the vacuum source and not to someother fluid collection assembly. Similarly, the gravity drainage port156 and/or proximal end of the bladder catheter 116 can comprise anotherconnector configuration to ensure that the bladder catheter 116 and notone of the ureteral catheters 112, 114 is permitted to drain by gravitydrainage. In other examples, the ports 154, 155, 156 and/or proximalends of the catheters 112, 114, 116 can include visual indicia to assistin correctly setting up the fluid collection system.

In some examples, urine received in the vacuum ports 154, 155 can bedirected through a Y-shaped conduit to a single vacuum outflow port 158located on a proximal side 160 of the connector 150. As inpreviously-described examples, the vacuum outflow port 158 can beconnected to the fluid collection container 712 and/or pump 710 bysuitable flexible tubing or other conduits for drawing urine from thebody and for inducing negative pressure in the ureters and/or kidneys.In some examples, the outflow port 156 and/or connector 150 can beconfigured to attach only to vacuum sources or pumps operating within apredetermined pressure range or power level to prevent exposing theureteral catheters 112, 114 to elevated levels or intensity of negativepressure. The proximal side 160 of the connector 150 can also comprise agravity outflow port 162 in fluid communication with the inflow port156. The gravity outflow port 162 can be configured to be connecteddirectly to the urine collection container 712 for urine collection bygravity drainage.

With continued reference to FIG. 17C, in some examples, in order tofacilitate system setup and implementation, the vacuum outflow port 158and the gravity outflow port 162 are disposed in close proximity so thata single socket 164, bracket, or connector can be coupled to theconnector 150 to establish fluid communication with each port 158, 162.The single socket or connector can be coupled to a multi-conduit hose ortube (e.g., flexible tubing 166) having a first conduit in fluidcommunication with the pump 710 and a second conduit in fluidcommunication with the collection container 712. Accordingly, a user caneasily set up the external fluid collection system by inserting thesingle socket 164 in the connector 150 and connecting the respectiveconduits to one of the fluid collection container 712 and pump 710(shown in FIG. 19). In other examples, a length of flexible tubing 166is connected between the urine collection container 712 and the gravityoutflow port 162, and a separate length of flexible tubing is connectedbetween the pump 710 and the vacuum outflow port 158.

Exemplary Fluid Sensors:

With reference again to FIG. 1, in some examples, the assembly 100further comprises sensors 174 for monitoring fluid characteristics ofurine being collected from the ureters 6, 8 and/or bladder 10. Asdiscussed herein in connection with FIG. 19, information obtained fromthe sensors 174 can be transmitted to a central data collection moduleor processor and used, for example, to control operation of an externaldevice, such as the pump 710 (shown in FIG. 19). The sensors 174 can beintegrally formed with one or more of the catheters 112, 114, 116 suchas, for example, embedded in a wall of the catheter body or tube and influid communication with drainage lumens 124, 140. In other examples,one or more of the sensors 174 can be positioned in a fluid collectioncontainer 712 (shown in FIG. 19) or in internal circuitry of an externaldevice, such as the pump 710.

Exemplary sensors 174 that can be used with the urine collectionassembly 100 can comprise one or more of the following sensor types. Forexample, the catheter assembly 100 can comprise a conductance sensor orelectrode that samples conductivity of urine. The normal conductance ofhuman urine is about 5-10 mS/m. Urine having a conductance outside ofthe expected range can indicate that the patient is experiencing aphysiological problem, which requires further treatment or analysis. Thecatheter assembly 100 can also comprise a flow meter for measuring aflow rate of urine through the catheter(s) 112, 114, 116. Flow rate canbe used to determine a total volume of fluid excreted from the body. Thecatheter(s) 112, 114, 116 can also comprise a thermometer for measuringurine temperature. Urine temperature can be used to collaborate theconductance sensor. Urine temperature can also be used for monitoringpurposes, as urine temperature outside of a physiologically normal rangecan be indicative of certain physiological conditions.

Method of Insertion of a Urine Collection Assembly:

Having described the urine collection assembly 100 including theureteral catheter retention portions and bladder anchor device (e.g., astandard or modified Foley-type catheter), methods for insertion anddeployment of the assemblies will now be discussed in detail.

With reference to FIG. 18A, steps for positioning a fluid collectionassembly in a patient's body and, optionally, for inducing negativepressure in a patient's ureter and/or kidneys are illustrated. As shownat box 610, a medical professional or caregiver inserts a flexible orrigid cystoscope through the patient's urethra and into the bladder toobtain visualization of the ureteral orifices or openings. Once suitablevisualization is obtained, as shown at box 612, a guidewire is advancedthrough the urethra, bladder, ureteral opening, ureter, and to a desiredfluid collection position, such as the renal pelvis of the kidney. Oncethe guidewire is advanced to the desired fluid collection position, aureteral catheter of the present invention (examples of which arediscussed in detail above) is inserted over the guidewire to the fluidcollection position, as shown at box 614. In some examples, the locationof the ureteral catheter can be confirmed by fluoroscopy, as shown atbox 616. Once the position of the distal end of the catheter isconfirmed, as shown at box 618, the retention portion of the ureteralcatheter can be deployed. For example, the guidewire can be removed fromthe catheter, thereby allowing the distal end and/or retention portionto transition to a deployed position. In some examples, the deployeddistal end portion of the catheter does not entirely occlude the ureterand/or renal pelvis, such that urine is permitted to pass outside thecatheter and through the ureters into the bladder. Since moving thecatheter can exert forces against urinary tract tissues, avoidingcomplete blockage of the ureters avoids application of force to theureter sidewalls, which may cause injury.

After the ureteral catheter is in place and deployed, the same guidewirecan be used to position a second ureteral catheter in the other ureterand/or kidney using the same insertion and positioning methods describedherein. For example, the cystoscope can be used to obtain visualizationof the other ureteral opening in the bladder, and the guidewire can beadvanced through the visualized ureteral opening to a fluid collectionposition in the other ureter. A catheter can be drawn alongside theguidewire and deployed in the manner described herein. Alternatively,the cystoscope and guidewire can be removed from the body. Thecystoscope can be reinserted into the bladder over the first ureteralcatheter. The cystoscope is used, in the manner described above, toobtain visualization of the ureteral opening and to assist in advancinga second guidewire to the second ureter and/or kidney for positioning ofthe second ureteral catheter. Once the ureteral catheters are in place,in some examples, the guidewire and cystoscope are removed. In otherexamples, the cystoscope and/or guidewire can remain in the bladder toassist with placement of the bladder catheter.

Optionally, a bladder catheter can also be used. Once the ureteralcatheters are in place, as shown at box 620, the medical professional orcaregiver can insert a distal end of a bladder catheter in a collapsedor contracted state through the urethra of the patient and into thebladder. The bladder catheter can be a conventional Foley bladdercatheter or a bladder catheter of the present invention as discussed indetail above. Once inserted in the bladder, as shown at box 622, ananchor connected to and/or associated with the bladder catheter isexpanded to a deployed position. For example, when an expandable orinflatable catheter is used, fluid may be directed through an inflationlumen of the bladder catheter to expand a balloon structure located inthe patient's bladder. In some examples, the bladder catheter isinserted through the urethra and into the bladder without using aguidewire and/or cystoscope. In other examples, the bladder catheter isinserted over the same guidewire used to position the ureteralcatheters. Accordingly, when inserted in this manner, the ureteralcatheters can be arranged to extend from the distal end of the bladdercatheter and, optionally, proximal ends of the ureteral catheters can bearranged to terminate in a drainage lumen of the bladder catheter.

In some examples, the urine is permitted to drain by gravity from theurethra. In other examples, a negative pressure is induced in theureteral catheter and/or bladder catheter to facilitate drainage of theurine.

With reference to FIG. 18B, steps for using the urine collectionassembly for inducement of negative pressure in the ureter(s) and/orkidney(s) are illustrated. As shown at box 624, after the indwellingportions of the bladder and/or ureteral catheters are correctlypositioned and anchoring/retention structures are deployed, the externalproximal ends of the catheter(s) are connected to fluid collection orpump assemblies. For example, the ureteral catheter(s) can be connectedto a pump for inducing negative pressure at the patient's renal pelvisand/or kidney. In a similar manner, the bladder catheter can beconnected directly to a urine collection container for gravity drainageof urine from the bladder or connected to a pump for inducing negativepressure at the bladder.

Once the catheter(s) and pump assembly are connected, negative pressureis applied to the renal pelvis and/or kidney and/or bladder through thedrainage lumens of the ureteral catheters and/or bladder catheter, asshown at box 626. The negative pressure is intended to countercongestion mediated interstitial hydrostatic pressures due to elevatedintra-abdominal pressure and consequential or elevated renal venouspressure or renal lymphatic pressure. The applied negative pressure istherefore capable of increasing flow of filtrate through the medullarytubules and of decreasing water and sodium re-absorption.

In some examples, mechanical stimulation can be provided to portions ofthe ureters and/or renal pelvis to supplement or modify therapeuticaffects obtained by application of negative pressure. For example,mechanical stimulation devices, such as linear actuators and other knowndevices for providing, for example, vibration waves, disposed in distalportions of the ureteral catheter(s) can be actuated. While notintending to be bound by theory, it is believed that such stimulationeffects adjacent tissues by, for example, stimulating nerves and/oractuating peristaltic muscles associated with the ureter(s) and/or renalpelvis. Stimulation of nerves and activation of muscles may producechanges in pressure gradients or pressure levels in surrounding tissuesand organs which may contribute to or, in some cases, enhancetherapeutic benefits of negative pressure therapy. In some examples, themechanical stimulation can comprise pulsating stimulation. In otherexamples, low levels of mechanical stimulation can be providedcontinuously as negative pressure is being provided through the ureteralcatheter(s). In other examples, inflatable portions of the ureteralcatheter could be inflated and deflated in a pulsating manner tostimulate adjacent nerve and muscle tissue, in a similar manner toactuation of the mechanical stimulation devices described herein.

As a result of the applied negative pressure, as shown at box 628, urineis drawn into the catheter at the plurality of drainage ports at thedistal end thereof, through the drainage lumen of the catheter, and to afluid collection container for disposal. As the urine is being drawn tothe collection container, at box 630, sensors disposed in the fluidcollection system provide a number of measurements about the urine thatcan be used to assess the volume of urine collected, as well asinformation about the physical condition of the patient and compositionof the urine produced. In some examples, the information obtained by thesensors is processed, as shown at box 632, by a processor associatedwith the pump and/or with another patient monitoring device and, at box634, is displayed to the user via a visual display of an associatedfeedback device.

Exemplary Fluid Collection System:

Having described an exemplary urine collection assembly and method ofpositioning such an assembly in the patient's body, with reference toFIG. 19, a system 700 for inducing negative pressure to a patient'sureter(s) and/or kidney(s) will now be described. The system 700 cancomprise the ureteral catheter(s), bladder catheter or the urinecollection assembly 100 described hereinabove. As shown in FIG. 19,ureteral catheters 112, 114 and/or the bladder catheter 116 of theassembly 100 are connected to one or more fluid collection containers712 for collecting urine drawn from the renal pelvis and/or bladder. Insome examples, the bladder catheter 116 and the ureteral catheters 112,114 are connected to different fluid collection containers 712. Thefluid collection container 712 connected to the ureteral catheter(s)112, 114 can be in fluid communication with an external fluid pump 710for generating negative pressure in the ureter(s) and kidney(s) throughthe ureteral catheter(s) 112, 114. As discussed herein, such negativepressure can be provided for overcoming interstitial pressure andforming urine in the kidney or nephron. In some examples, a connectionbetween the fluid collection container 712 and pump 710 can comprise afluid lock or fluid barrier to prevent air from entering the renalpelvis or kidney in case of incidental therapeutic or non-therapeuticpressure changes. For example, inflow and outflow ports of the fluidcontainer can be positioned below a fluid level in the container.Accordingly, air is prevented from entering medical tubing or thecatheter through either the inflow or outflow ports of the fluidcontainer 712. As discussed previously, external portions of the tubingextending between the fluid collection container 712 and the pump 710can include one or more filters to prevent urine and/or particulatesfrom entering the pump 710.

As shown in FIG. 19, the system 700 further comprises a controller 714,such as a microprocessor, electronically coupled to the pump 710 andhaving or associated with computer readable memory 716. In someexamples, the memory 716 comprises instructions that, when executed,cause the controller 714 to receive information from sensors 174 locatedon or associated with portions of the assembly 100. Information about acondition of the patient can be determined based on information from thesensors 174. Information from the sensors 174 can also be used todetermine and implement operating parameters for the pump 710.

In some examples, the controller 714 is incorporated in a separate andremote electronic device in communication with the pump 710, such as adedicated electronic device, computer, tablet PC, or smart phone.Alternatively, the controller 714 can be included in the pump 710 and,for example, can control both a user interface for manually operatingthe pump 710, as well as system functions such as receiving andprocessing information from the sensors 174.

The controller 714 is configured to receive information from the one ormore sensors 174 and to store the information in the associatedcomputer-readable memory 716. For example, the controller 714 can beconfigured to receive information from the sensor 174 at a predeterminedrate, such as once every second, and to determine a conductance based onthe received information. In some examples, the algorithm forcalculating conductance can also include other sensor measurements, suchas urine temperature, to obtain a more robust determination ofconductance.

The controller 714 can also be configured to calculate patient physicalstatistics or diagnostic indicators that illustrate changes in thepatient's condition over time. For example, the system 700 can beconfigured to identify an amount of total sodium excreted. The totalsodium excreted may be based, for example, on a combination of flow rateand conductance over a period of time.

With continued reference to FIG. 19, the system 700 can further comprisea feedback device 720, such as a visual display or audio system, forproviding information to the user. In some examples, the feedback device720 can be integrally formed with the pump 710. Alternatively, thefeedback device 720 can be a separate dedicated or a multipurposeelectronic device, such as a computer, laptop computer, tablet PC, smartphone, or other handheld electronic devices. The feedback device 720 isconfigured to receive the calculated or determined measurements from thecontroller 714 and to present the received information to a user via thefeedback device 720. For example, the feedback device 720 may beconfigured to display current negative pressure (in mmHg) being appliedto the urinary tract. In other examples, the feedback device 720 isconfigured to display current flow rate of urine, temperature, currentconductance in mS/m of urine, total urine produced during the session,total sodium excreted during the session, other physical parameters, orany combination thereof.

In some examples, the feedback device 720 further comprises a userinterface module or component that allows the user to control operationof the pump 710. For example, the user can engage or turn off the pump710 via the user interface. The user can also adjust pressure applied bythe pump 710 to achieve a greater magnitude or rate of sodium excretionand fluid removal.

Optionally, the feedback device 720 and/or pump 710 further comprise adata transmitter 722 for sending information from the device 720 and/orpump 710 to other electronic devices or computer networks. The datatransmitter 722 can utilize a short-range or long-range datacommunications protocol. An example of a short-range data transmissionprotocol is Bluetooth®. Long-range data transmission networks include,for example, Wi-Fi or cellular networks. The data transmitter 722 cansend information to a patient's physician or caregiver to inform thephysician or caregiver about the patient's current condition.Alternatively, or in addition, information can be sent from the datatransmitter 722 to existing databases or information storage locations,such as, for example, to include the recorded information in a patient'selectronic health record (EHR).

With reference to FIGS. 20A and 20B, an exemplary pump 710 for use withthe system is illustrated. In some examples, the pump 710 is amicro-pump configured to draw fluid from the catheter(s) 112, 114(shown, for example, in FIG. 1) and having a sensitivity or accuracy ofabout 10 mmHg or less. Desirably, the pump 710 is capable of providing arange of flow of urine between 0.05 ml/min and 3 ml/min for extendedperiods of time, for example, for about 8 hours to about 24 hours perday, for one (1) to about 30 days or longer. At 0.2 ml/min, it isanticipated that about 300 mL of urine per day is collected by thesystem 700. The pump 710 can be configured to provide a negativepressure to the bladder of the patient, the negative pressure rangingbetween about 0.1 mmHg and 50 mmHg or about 5 mmHg to about 20 mmHg(gauge pressure at the pump 710). For example, a micro-pump manufacturedby Langer Inc. (Model BT100-2J) can be used with the presently disclosedsystem 700. Diaphragm aspirator pumps, as well as other types ofcommercially available pumps, can also be used for this purpose.Peristaltic pumps can also be used with the system 700. In otherexamples, a piston pump, vacuum bottle, or manual vacuum source can beused for providing negative pressure. In other examples, the system canbe connected to a wall suction source, as is available in a hospital,through a vacuum regulator for reducing negative pressure totherapeutically appropriate levels.

In some examples, the pump 710 is configured for extended use and, thus,is capable of maintaining precise suction for extended periods of time,for example, for about 8 hours to about 24 hours per day, for 1 to about30 days or longer. Further, in some examples, the pump 710 is configuredto be manually operated and, in that case, includes a control panel 718that allows a user to set a desired suction value. The pump 710 can alsoinclude a controller or processor, which can be the same controller thatoperates the system 700 or can be a separate processor dedicated foroperation of the pump 710. In either case, the processor is configuredfor both receiving instructions for manual operation of the pump and forautomatically operating the pump 710 according to predeterminedoperating parameters. Alternatively, or in addition, operation of thepump 710 can be controlled by the processor based on feedback receivedfrom the plurality of sensors associated with the catheter.

In some examples, the processor is configured to cause the pump 710 tooperate intermittently. For example, the pump 710 may be configured toemit pulses of negative pressure followed by periods in which nonegative pressure is provided. In other examples, the pump 710 can beconfigured to alternate between providing negative pressure and positivepressure to produce an alternating flush and pump effect. For example, apositive pressure of about 0.1 mmHg to 20 mmHg, and preferably about 5mmHg to 20 mmHg can be provided followed by a negative pressure rangingfrom about 0.1 mmHg to 50 mmHg.

Experimental Examples

Inducement of negative pressure within the renal pelvis of farm swinewas performed for the purpose of evaluating effects of negative pressuretherapy on renal congestion in the kidney. An objective of these studieswas to demonstrate whether a negative pressure delivered into the renalpelvis significantly increases urine output in a swine model of renalcongestion. In Example 1, a pediatric Fogarty catheter, normally used inembolectomy or bronchoscopy applications, was used in the swine modelsolely for proof of principle for inducement of negative pressure in therenal pelvis. It is not suggested that a Fogarty catheter be used inhumans in clinical settings to avoid injury of urinary tract tissues. InExample 2, the ureteral catheter 112 shown in FIGS. 2A and 2B, andincluding a helical retention portion for mounting or maintaining adistal portion of the catheter in the renal pelvis or kidney, was used.

Example 1

Method

Four farm swine 800 were used for purposes of evaluating effects ofnegative pressure therapy on renal congestion in the kidney. As shown inFIG. 21, pediatric Fogarty catheters 812, 814 were inserted to the renalpelvis region 820, 821 of each kidney 802, 804 of the four swine 800.The catheters 812, 814 were deployed within the renal pelvis region byinflating an expandable balloon to a size sufficient to seal the renalpelvis and to maintain the position of the balloon within the renalpelvis. The catheters 812, 814 extend from the renal pelvis 802, 804,through a bladder 810 and urethra 816, and to fluid collectioncontainers external to the swine.

Urine output of two animals was collected for a 15 minute period toestablish a baseline for urine output volume and rate. Urine output ofthe right kidney 802 and the left kidney 804 were measured individuallyand found to vary considerably. Creatinine clearance values were alsodetermined.

Renal congestion (e.g., congestion or reduced blood flow in the veins ofthe kidney) was induced in the right kidney 802 and the left kidney 804of the animal 800 by partially occluding the inferior vena cava (IVC)with an inflatable balloon catheter 850 just above to the renal veinoutflow. Pressure sensors were used to measure IVC pressure. Normal IVCpressures were 1-4 mmHg. By inflating the balloon of the catheter 850 toapproximately three quarters of the IVC diameter, the IVC pressures wereelevated to between 15-25 mmHg. Inflation of the balloon toapproximately three quarters of IVC diameter resulted in a 50-85%reduction in urine output. Full occlusion generated IVC pressures above28 mmHg and was associated with at least a 95% reduction in urineoutput.

One kidney of each animal 800 was not treated and served as a control(“the control kidney 802”). The ureteral catheter 812 extending from thecontrol kidney was connected to a fluid collection container 819 fordetermining fluid levels. One kidney (“the treated kidney 804”) of eachanimal was treated with negative pressure from a negative pressuresource (e.g., a therapy pump 818 in combination with a regulatordesigned to more accurately control the low magnitude of negativepressures) connected to the ureteral catheter 814. The pump 818 was anAir Cadet Vacuum Pump from Cole-Parmer Instrument Company (Model No.EW-07530-85). The pump 818 was connected in series to the regulator. Theregulator was an V-800 Series Miniature Precision Vacuum Regulator—⅛ NPTPorts (Model No. V-800-10-W/K), manufactured by Airtrol Components Inc.

The pump 818 was actuated to induce negative pressure within the renalpelvis 820, 821 of the treated kidney according to the followingprotocol. First, the effect of negative pressure was investigated in thenormal state (e.g., without inflating the IVC balloon). Four differentpressure levels (−2, −10, −15, and −20 mmHg) were applied for 15 minuteseach and the rate of urine produced and creatinine clearance weredetermined. Pressure levels were controlled and determined at theregulator. Following the −20 mmHg therapy, the IVC balloon was inflatedto increase the pressure by 15-20 mmHg. The same four negative pressurelevels were applied. Urine output rate and creatinine clearance rate forthe congested control kidney 802 and treated kidney 804 were obtained.The animals 800 were subject to congestion by partial occlusion of theIVC for 90 minutes. Treatment was provided for 60 minutes of the 90minute congestion period.

Following collection of urine output and creatinine clearance data,kidneys from one animal were subjected to gross examination then fixedin a 10% neutral buffered formalin. Following gross examination,histological sections were obtained, examined, and magnified images ofthe sections were captured. The sections were examined using an uprightOlympus BX41 light microscope and images were captured using an OlympusDP25 digital camera. Specifically, photomicrograph images of the sampledtissues were obtained at low magnification (20× original magnification)and high magnification (100× original magnification). The obtainedimages were subjected to histological evaluation. The purpose of theevaluation was to examine the tissue histologically and to qualitativelycharacterize congestion and tubular degeneration for the obtainedsamples.

Surface mapping analysis was also performed on obtained slides of thekidney tissue. Specifically, the samples were stained and analyzed toevaluate differences in size of tubules for treated and untreatedkidneys. Image processing techniques calculated a number and/or relativepercentage of pixels with different coloration in the stained images.Calculated measurement data was used to determine volumes of differentanatomical structures.

Results

Urine Output and Creatinine Clearance

Urine output rates were highly variable. Three sources of variation inurine output rate were observed during the study. The inter-individualand hemodynamic variability were anticipated sources of variabilityknown in the art. A third source of variation in urine output, uponinformation and belief believed to be previously unknown, was identifiedin the experiments discussed herein, namely, contralateralintra-individual variability in urine output.

Baseline urine output rates were 0.79 ml/min for one kidney and 1.07ml/min for the other kidney (e.g., a 26% difference). The urine outputrate is a mean rate calculated from urine output rates for each animal.

When congestion was provided by inflating the IVC balloon, the treatedkidney urine output dropped from 0.79 ml/min to 0.12 ml/min (15.2% ofbaseline). In comparison, the control kidney urine output rate duringcongestion dropped from 1.07 ml/min to 0.09 ml/min (8.4% of baseline).Based on urine output rates, a relative increase in treated kidney urineoutput compared to control kidney urine output was calculated, accordingto the following equation:

(Therapy Treated/Baseline Treated)/(Therapy Control/BaselineControl)=Relative increase

(0.12 ml/min/0.79 ml/min)/(0.09 ml/min/1.07 ml/min)=180.6%

Thus, the relative increase in treated kidney urine output rate was180.6% compared to control. This result shows a greater magnitude ofdecrease in urine production caused by congestion on the control sidewhen compared to the treatment side. Presenting results as a relativepercentage difference in urine output adjusts for differences in urineoutput between kidneys.

Creatinine clearance measurements for baseline, congested, and treatedportions for one of the animals are shown in FIG. 22.

Gross Examination and Histological Evaluation

Based on gross examination of the control kidney (right kidney) andtreated kidney (left kidney), it was determined that the control kidneyhad a uniformly dark red-brown color, which corresponds with morecongestion in the control kidney compared to the treated kidney.Qualitative evaluation of the magnified section images also notedincreased congestion in the control kidney compared to the treatedkidney. Specifically, as shown in Table 1, the treated kidney exhibitedlower levels of congestion and tubular degeneration compared to thecontrol kidney. The following qualitative scale was used for evaluationof the obtained slides.

Congestion

Lesion Score None: 0 Mild: 1 Moderate: 2 Marked: 3 Severe: 4

Tubular Degeneration

Lesion Score None: 0 Mild: 1 Moderate: 2 Marked: 3 Severe: 4

TABLE 1 TABULATED RESULTS Histologic lesions Slide Tubular AnimalID/Organ/Gross lesion number Congestion byaline casts Granulomas6343/Left Kidney/Normal R16-513-1 1 1 0 6343/Left Kidney/NormalR16-513-2 1 1 0 with hemorrhagic streak 6343/Right Kidney/CongestionR16-513-3 2 2 1 6343/Right Kidney/Congestion R16-513-4 2 1 1

As shown in Table 1, the treated kidney (left kidney) exhibited onlymild congestion and tubular degeneration. In contrast, the controlkidney (right kidney) exhibited moderate congestion and tubulardegeneration. These results were obtained by analysis of the slidesdiscussed below.

FIGS. 23A and 23B are low and high magnification photomicrographs of theleft kidney (treated with negative pressure) of the animal. Based on thehistological review, mild congestion in the blood vessels at thecorticomedullary junction was identified, as indicated by the arrows. Asshown in FIG. 23B, a single tubule with a hyaline cast (as identified bythe asterisk) was identified.

FIGS. 23C and 23D are low and high resolution photomicrographs of thecontrol kidney (right kidney). Based on the histological review,moderate congestion in the blood vessel at the corticomedullary junctionwas identified, as shown by the arrows in FIG. 23C. As shown in FIG.23D, several tubules with hyaline casts were present in the tissuesample (as identified by asterisks in the image). Presence of asubstantial number of hyaline casts is evidence of hypoxia.

Surface mapping analysis provided the following results. The treatedkidney was determined to have 1.5 times greater fluid volume in Bowman'sspace and 2 times greater fluid volume in tubule lumen. Increased fluidvolume in Bowman's space and the tubule lumen corresponds to increasedurine output. In addition, the treated kidney was determined to have 5times less blood volume in capillaries compared to the control kidney.The increased volume in the treated kidney appears to be a result of (1)a decrease in individual capillary size compared to the control and (2)an increase in the number of capillaries without visible red blood cellsin the treated kidney compared to the control kidney, an indicator ofless congestion in the treated organ.

Summary

These results indicate that the control kidney had more congestion andmore tubules with intraluminal hyaline casts, which representprotein-rich intraluminal material, compared to the treated kidney.Accordingly, the treated kidney exhibits a lower degree of loss of renalfunction. While not intending to be bound by theory, it is believed thatas severe congestion develops in the kidney, hypoxemia of the organfollows. Hypoxemia interferes with oxidative phosphorylation within theorgan (e.g., ATP production). Loss of ATP and/or a decrease in ATPproduction inhibits the active transport of proteins causingintraluminal protein content to increase, which manifests as hyalinecasts. The number of renal tubules with intraluminal hyaline castscorrelates with the degree of loss of renal function. Accordingly, thereduced number of tubules in the treated left kidney is believed to bephysiologically significant. While not intending to be bound by theory,it is believed that these results show that damage to the kidney can beprevented or inhibited by applying negative pressure to a catheterinserted into the renal pelvis to facilitate urine output.

Example 2

Method

Four (4) farm swine (A, B, C, D) were sedated and anesthetized. Vitalsfor each of the swine were monitored throughout the experiment andcardiac output was measured at the end of each 30-minute phase of thestudy. Ureteral catheters, such as the ureteral catheter 112 shown inFIGS. 2A and 2B, were deployed in the renal pelvis region of the kidneysof each of the swine. The deployed catheters were a 6 Fr catheter havingan outer diameter of 2.0±0.1 mm. The catheters were 54±2 cm in length,not including the distal retention portion. The retention portion was16±2 mm in length. As shown in the catheter 112 in FIGS. 2A and 2B, theretention portion included two full coils and one proximal half coil.The outer diameter of the full coils, shown by line D1 in FIGS. 2A and2B, was 18±2 mm. The half coil diameter D2 was about 14 mm. Theretention portion of the deployed ureteral catheters included sixdrainage holes, plus an additional hole at the distal end of thecatheter tube. The diameter of each of the drainage holes was 0.83±0.01mm. The distance between adjacent drainage holes 132, specifically thelinear distance between drainage holes when the coils were straightened,was 22.5±2.5 mm.

The ureteral catheters were positioned to extend from the renal pelvisof the swine, through the bladder, and urethra, and to fluid collectioncontainers external to each swine.

Following placement of the ureteral catheters, pressure sensors formeasuring IVC pressure were placed in the IVC at a position distal tothe renal veins. An inflatable balloon catheter, specifically a PTS®percutaneous balloon catheter (30 mm diameter by 5 cm length),manufactured by NuMED Inc. of Hopkinton, N.Y., was expanded in the IVCat a position proximal to the renal veins. A thermodilution catheter,specifically a Swan-Ganz thermodilution pulmonary artery cathetermanufactured by Edwards Lifesciences Corp. of Irvine, Calif., was thenplaced in the pulmonary artery for the purpose of measuring cardiacoutput.

Initially, baseline urine output was measured for 30 minutes, and bloodand urine samples were collected for biochemical analysis. Following the30-minute baseline period, the balloon catheter was inflated to increaseIVC pressure from a baseline pressure of 1-4 mmHg to an elevatedcongested pressure of about 20 mmHg (+/−5 mmHg). A congestion baselinewas then collected for 30 minutes with corresponding blood and urineanalysis.

At the end of the congestion period, the elevated congested IVC pressurewas maintained and negative pressure diuresis treatment was provided forswine A and swine C. Specifically, the swine (A, C) were treated byapplying a negative pressure of −25 mmHg through the ureteral catheterswith a pump. As in previously-discussed examples, the pump was an AirCadet Vacuum Pump from Cole-Parmer Instrument Company (Model No.EW-07530-85). The pump was connected in series to a regulator. Theregulator was a V-800 Series Miniature Precision Vacuum Regulator—⅛ NPTPorts (Model No. V-800-10-W/K), manufactured by Airtrol Components Inc.The swine were observed for 120 minutes, as treatment was provided.Blood and urine collection were performed every 30 minutes, during thetreatment period. Two of the swine (B, D) were treated as congestedcontrols (e.g., negative pressure was not applied to the renal pelvisthrough the ureteral catheters), meaning that the two swine (B, D) didnot receive negative pressure diuresis therapy.

Following collection of urine output and creatinine clearance data forthe 120-minute treatment period, the animals were sacrificed and kidneysfrom each animal were subjected to gross examination. Following grossexamination, histological sections were obtained and examined, andmagnified images of the sections were captured.

Results

Measurements collected during the Baseline, Congestion, and Treatmentperiods are provided in Table 2. Specifically, urine output, serumcreatinine, and urinary creatinine measurements were obtained for eachtime period. These values allow for the calculation of a measuredcreatinine clearance as follows:

${{Creatinine}\mspace{14mu}{Clearance}\text{:}\mspace{14mu}{CrCl}} = {{Urine}\mspace{14mu}{Output}\mspace{14mu}\left( {{ml}\text{/}\min} \right)*\frac{{Urinary}\mspace{14mu}{Creatinine}\mspace{14mu}\left( {{mg}\text{/}{dl}} \right)}{{Serum}\mspace{14mu}{Creatinine}\mspace{14mu}\left( {{mg}\text{/}{dl}} \right)}}$

In addition, Neutrophil gelatinase-associated lipocalin (NGAL) valueswere measured from serum samples obtained for each time period andKidney Injury Molecule 1 (KIM-1) values were measured from the urinesamples obtained for each time period. Qualitative histological findingsdetermined from review of the obtained histological sections are alsoincluded in Table 2.

TABLE 2 Animal A B C D Treatment assignment Treatment Control TreatmentControl Baseline: Urine output (ml/min) 3.01 2.63 0.47 0.98 Serumcreatinine (mg/dl) 0.8 0.9 3.2 1.0 Creatinine clearance (ml/min) 261 1725.4 46.8 Serum NGAL (ng/ml) 169 * 963 99 Urinary KIM-1 (ng/ml) 4.11 *3.59 1.16 Congestion: Urine output (ml/min) 0.06 (2%)   0.53 (20%)  0.12 (25%)   0.24 (25%)  Serum creatinine (mg/dl)  1.2 (150%)   1.1(122%)  3.1 (97%)   1.2 (120%)  Creatinine clearance (ml/min) 1.0 (0.4%)30.8 (18%)   1.6 (21%)  16.2 (35%)   Serum NGAL (ng/ml) 102 (60%)  * 809(84%)  126 (127%) Urinary KIM-1 (ng/ml) 24.3 (591%)  * 2.2 (61%)  1.39(120%)  Treatment: Urine output (ml/min) 0.54 (17%)   ** 0.47 (101%) 0.35 (36%)   Serum creatinine (mg/dl)  1.3 (163%)  3.1 (97%)   1.7(170%)  Creatinine clearance (ml/min) 30.6 (12%)   18.3 (341%)  13.6(29%)   Serum NGAL (ng/ml) 197 (117%) 1104 (115%)  208 (209%) UrinaryKIM-1 (ng/ml)  260 (6326%) 28.7 (799%)   233 (20000%) Histologicalfindings: Blood volume in capillary space 2.4% ** 0.9% 4.0% Hyalinecasts Mild/Mod None Mod Degranulation Mild/Mod None Mod Data are rawvalues (% baseline) * not measured ** confounded by phenylephrine

Animal A:

The animal weighed 50.6 kg and had a baseline urine output rate of 3.01ml/min, a baseline serum creatinine of 0.8 mg/dl, and a measured CrCl of261 ml/min. It is noted that these measurements, aside from serumcreatinine, were uncharacteristically high relative to other animalsstudied. Congestion was associated with a 98% reduction in urine outputrate (0.06 ml/min) and a >99% reduction in CrCl (1.0 ml/min). Treatmentwith negative pressure applied through the ureteral catheters wasassociated with urine output and CrCl of 17% and 12%, respectively, ofbaseline values, and 9× and >10×, respectively, of congestion values.Levels of NGAL changed throughout the experiment, ranging from 68% ofbaseline during congestion to 258% of baseline after 90 minutes oftherapy. The final value was 130% of baseline. Levels of KIM-1 were 6times and 4 times of baseline for the first two 30-minute windows afterbaseline assessment, before increasing to 68×, 52×, and 63× of baselinevalues, respectively, for the last three collection periods. The 2-hourserum creatinine was 1.3 mg/dl. Histological examination revealed anoverall congestion level, measured by blood volume in capillary space,of 2.4%. Histological examination also noted several tubules withintraluminal hyaline casts and some degree of tubular epithelialdegeneration, a finding consistent with cellular damage.

Animal B:

The animal weighed 50.2 kg and had a baseline urine output rate of 2.62ml/min and a measured CrCl of 172 ml/min (also higher than anticipated).Congestion was associated with an 80% reduction in urine output rate(0.5 ml/min) and an 83% reduction in CrCl (30 ml/min). At 50 minutesinto the congestion (20 minutes after the congestion baseline period),the animal experienced an abrupt drop in mean arterial pressure andrespiration rate, followed by tachycardia. The anesthesiologistadministered a dose of phenylephrine (75 mg) to avert cardiogenic shock.Phenylephrine is indicated for intravenous administration when bloodpressure drops below safe levels during anesthesia. However, since theexperiment was testing the impact of congestion on renal physiology,administration of phenylephrine confounded the remainder of theexperiment.

Animal C:

The animal weighed 39.8 kg and had a baseline urine output rate of 0.47ml/min, a baseline serum creatinine of 3.2 mg/dl, and a measured CrCl of5.4 ml/min. Congestion was associated with a 75% reduction in urineoutput (0.12 ml/min) and a 79% reduction in CrCl (1.6 ml/min). It wasdetermined that baseline NGAL levels were >5× the upper limit of normal(ULN). Treatment with negative pressure applied to the renal pelvisthrough the ureteral catheters was associated with a normalization ofurine output (101% of baseline) and a 341% improvement in CrCl (18.2ml/min). Levels of NGAL changed throughout the experiment, ranging from84% of baseline during congestion to 47% to 84% of baseline between 30and 90 minutes. The final value was 115% of baseline. Levels of KIM-1decreased 40% from baseline within the first 30 minutes of congestion,before increasing to 8.7×, 6.7×, 6.6×, and 8× of baseline values,respectively, for the remaining 30-minute windows. Serum creatininelevel at 2 hours was 3.1 mg/dl. Histological examination revealed anoverall congestion level, measured by blood volume in capillary space,of 0.9%. The tubules were noted to be histologically normal.

Animal D:

The animal weighed 38.2 kg and had a baseline urine output of 0.98ml/min, a baseline serum creatinine of 1.0 mg/dl, and a measured CrCl of46.8 ml/min. Congestion was associated with a 75% reduction in urineoutput rate (0.24 ml/min) and a 65% reduction in Cr Cl (16.2 ml/min).Continued congestion was associated with a 66% to 91% reduction of urineoutput and 89% to 71% reduction in CrCl. Levels of NGAL changedthroughout the experiment, ranging from 127% of baseline duringcongestion to a final value of 209% of baseline. Levels of KIM-1remained between 1× and 2× of baseline for the first two 30-minutewindows after baseline assessment, before increasing to 190×, 219×, and201× of baseline values for the last three 30-minute periods. The 2-hourserum creatinine level was 1.7 mg/dl. Histological examination revealedan overall congestion level 2.44× greater than that observed in tissuesamples for the treated animals (A, C) with an average capillary size2.33 times greater than that observed in either of the treated animals.The histological evaluation also noted several tubules with intraluminalhyaline casts as well as tubular epithelial degeneration, indicatingsubstantial cellular damage.

Summary

While not intending to be bound by theory, it is believed that thecollected data supports the hypothesis that venous congestion creates aphysiologically significant impact on renal function. In particular, itwas observed that elevation of the renal vein pressure reduced urineoutput by 75% to 98% within seconds. The association between elevationsin biomarkers of tubular injury and histological damage is consistentwith the degree of venous congestion generated, both in terms ofmagnitude and duration of the injury.

The data also appears to support the hypothesis that venous congestiondecreases the filtration gradients in the medullary nephrons by alteringthe interstitial pressures. The change appears to directly contribute tothe hypoxia and cellular injury within medullary nephrons. While thismodel does not mimic the clinical condition of AKI, it does provideinsight into the mechanical sustaining injury.

The data also appears to support the hypothesis that applying negativepressure to the renal pelvis through ureteral catheters can increaseurine output in a venous congestion model. In particular, negativepressure treatment was associated with increases in urine output andcreatinine clearance that would be clinically significant.Physiologically meaningful decreases in medullary capillary volume andsmaller elevations in biomarkers of tubular injury were also observed.Thus, it appears that by increasing urine output rate and decreasinginterstitial pressures in medullary nephrons, negative pressure therapymay directly decrease congestion. While not intending to be bound bytheory, by decreasing congestion, it may be concluded that negativepressure therapy reduces hypoxia and its downstream effects within thekidney in a venous congestion mediated AKI.

The experimental results appear to support the hypothesis that thedegree of congestion, both in terms of the magnitude of pressure andduration, is associated with the degree of cellular injury observed.Specifically, an association between the degree of urine outputreduction and the histological damage was observed. For example, treatedSwine A, which had a 98% reduction in urine output, experienced moredamage than treated Swine C, which had a 75% reduction in urine output.As would be expected, control Swine D, which was subjected to a 75%reduction in urine output without benefit of therapy for two and a halfhours, exhibited the most histological damage. These findings arebroadly consistent with human data demonstrating an increased risk forAKI onset with greater venous congestion. See e.g., Legrand, M. et al.,Association between systemic hemodynamics and septic acute kidney injuryin critically ill patients: a retrospective observational study.Critical Care 17:R278-86, 2013.

The preceding examples and embodiments of the invention have beendescribed with reference to various examples. Modifications andalterations will occur to others upon reading and understanding theforegoing examples. Accordingly, the foregoing examples are not to beconstrued as limiting the disclosure.

What is claimed is:
 1. A negative pressure therapy system for increasingurine production, the negative pressure therapy system comprising: (a) apump assembly, the pump assembly comprising: (i) a pump configured toprovide negative pressure to a kidney, and (ii) a controller configuredto regulate the negative pressure provided by the pump within a pressurerange that facilitates increased urine production from the kidney. 2.The negative pressure therapy system of claim 1, wherein the controllerregulates the negative pressure provided by the pump based upon changesin physiological condition.
 3. The negative pressure therapy system ofclaim 2, further comprising one or more sensors that detect change(s) inthe physiological condition, wherein the controller regulates thenegative pressure provided by the pump based upon information measuredby the one or more sensors.
 4. The negative pressure therapy system ofclaim 1, wherein the controller is integrated into the pump.
 5. Thenegative pressure therapy system of claim 1, wherein the controller islocated outside of a body.
 6. The negative pressure therapy system ofclaim 1, wherein the pump is located outside of a body.
 7. The negativepressure therapy system of claim 1, wherein the pump is located within abody.
 8. The negative pressure therapy system of claim 7, wherein thepump is located within a urinary tract.
 9. The negative pressure therapysystem of claim 1, further comprising a catheter having (i) a proximalportion comprising a drainage lumen and (ii) a distal portion comprisinga retention portion configured to be positioned in a urinary tract, theretention portion comprising one or more drainage ports that permitfluid flow into the drainage lumen.
 10. The negative pressure therapysystem of claim 9, wherein the proximal portion of the catheter isconfigured to be connected to the pump to provide negative pressurethrough the catheter to the kidney.
 11. The negative pressure therapysystem of claim 10, wherein the retention portion is configured suchthat, when the pump provides negative pressure through the catheter,fluid is drawn into the one or more drainage ports while mucosal tissueis prevented from appreciably occluding the one or more drainage ports.12. The negative pressure therapy system of claim 11, wherein the one ormore drainage ports are located on a radially inwardly facing side ofthe retention portion and, when the pump provides negative pressurethrough the catheter, a radially outwardly facing side of the retentionportion inhibits mucosal tissue from contacting the one or more drainageports.
 13. The negative pressure therapy system of claim 12, wherein theradially outwardly facing side of the retention portion is essentiallyfree of drainage ports.
 14. The negative pressure therapy system ofclaim 1, wherein the pump is configured to provide negative pressure toa kidney of a patient, and (ii) the controller is configured to regulatethe negative pressure provided by the pump within a pressure range thatfacilitates increased urine production from the kidney of the patient.15. A negative pressure therapy system for increasing urine production,the negative pressure therapy system comprising: (a) a pump assembly,the pump assembly comprising: (i) a pump configured to provide negativepressure to a kidney, and (ii) a controller configured to regulate thenegative pressure provided by the pump, based upon changes inphysiological condition, so as to facilitate increased urine productionfrom the kidney.
 16. The negative pressure therapy system of claim 15,further comprising one or more sensors that detect change(s) in thephysiological condition, wherein the controller regulates the negativepressure provided by the pump based upon information measured by the oneor more sensors.
 17. The negative pressure therapy system of claim 16,wherein the controller is integrated into the pump.
 18. The negativepressure therapy system of claim 16, wherein the controller is locatedoutside of a body.
 19. The negative pressure therapy system of claim 16,wherein the pump is located outside of a body.
 20. The negative pressuretherapy system of claim 16, wherein the pump is located within a body.21. The negative pressure therapy system of claim 20, wherein the pumpis located within a urinary tract.
 22. The negative pressure therapysystem of claim 16, further comprising a catheter having (i) a proximalportion comprising a drainage lumen and (ii) a distal portion comprisinga retention portion configured to be positioned in a urinary tract, theretention portion comprising one or more drainage ports that permitfluid flow into the drainage lumen.
 23. The negative pressure therapysystem of claim 22, wherein the proximal portion of the catheter isconfigured to be connected to the pump to provide negative pressurethrough the catheter to the kidney.
 24. The negative pressure therapysystem of claim 23, wherein the retention portion is configured suchthat, when the pump provides negative pressure through the catheter,fluid is drawn into the one or more drainage ports while mucosal tissueis prevented from appreciably occluding the one or more drainage ports.25. The negative pressure therapy system of claim 24, wherein the one ormore drainage ports are located on a radially inwardly facing side ofthe retention portion and, when the pump provides negative pressurethrough the catheter, a radially outwardly facing side of the retentionportion inhibits mucosal tissue from contacting the one or more drainageports.
 26. The negative pressure therapy system of claim 25, wherein theradially outwardly facing side of the retention portion is essentiallyfree of drainage ports.
 27. The negative pressure therapy system ofclaim 15, wherein the pump is configured to provide negative pressure tothe kidney of a patient, and (ii) the controller is configured toregulate the negative pressure provided by the pump, based upon changesin the physiological condition of the patient, so as to facilitateincreased urine production from the kidney of the patient.